Trial Outcomes & Findings for Study of MLN2480 in Participants With Relapsed or Refractory Solid Tumors Followed by a Dose Expansion in Participants With Metastatic Melanoma (NCT NCT01425008)
NCT ID: NCT01425008
Last Updated: 2020-08-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
149 participants
Primary outcome timeframe
Baseline up to 30 days after last dose, or start of subsequent therapy, whichever occurred first (up to Cycle 38 Days 52 [Q2D] and 58 [QW] [Cycle=22 days (Q2D) and 28 days (QW)] in Escalation Phase; Cycle 49 Day 58 [Cycle=28 days] in Expansion Phase)
Results posted on
2020-08-10
Participant Flow
Participants took part in the study at 16 investigative sites in the United States and United Kingdom from 13 September 2011 to 16 October 2018.
Participants with relapsed and refractory solid tumors and metastatic melanoma were enrolled in Dose Escalation Phase and Dose Expansion Phase respectively to receive TAK-580 (MLN2480), once every other day (Q2D) or once weekly (QW). Q2D Dose Expansion Phase, TAK-580 (BRAF+) was discontinued due to sponsor's decision of strategic deprioritization.
Participant milestones
| Measure |
Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle)
TAK-580 20 milligram (mg), tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle)
TAK-580 40 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle)
TAK-580 80 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle)
TAK-580 135 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle)
TAK-580 200 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle)
TAK-580 280 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)
TAK-580 400 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)
TAK-580 800 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Naive)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, naive to prior therapy with rapidly accelerated fibrosarcoma (RAF) and mitogen-activated protein kinase (MEPK kinase) or extracellular signal-regulated kinase (ERK kinase) (MEK) inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, which in response to previous treatment with RAF inhibitors and/or MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, which in response to previous treatment with MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative cutaneous melanoma (wild type \[WT\]), naive to any prior anticancer therapy except ipilimumab, anti-programmed cell death-1 (PD-1), and anti-PD ligand-1 (PDL-1) monoclonal antibodies.
|
Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative melanoma (WT), who had received at least 1 line of prior anticancer therapy.
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF-mutation positive cutaneous melanoma.
|
QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49), in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase
STARTED
|
4
|
3
|
3
|
3
|
7
|
7
|
3
|
3
|
13
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation Phase
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation Phase
NOT COMPLETED
|
4
|
3
|
3
|
3
|
7
|
7
|
3
|
3
|
13
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion Phase
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
16
|
8
|
16
|
1
|
6
|
11
|
20
|
2
|
19
|
|
Dose Expansion Phase
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
15
|
8
|
16
|
1
|
6
|
11
|
20
|
2
|
19
|
Reasons for withdrawal
| Measure |
Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle)
TAK-580 20 milligram (mg), tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle)
TAK-580 40 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle)
TAK-580 80 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle)
TAK-580 135 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle)
TAK-580 200 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle)
TAK-580 280 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)
TAK-580 400 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)
TAK-580 800 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Naive)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, naive to prior therapy with rapidly accelerated fibrosarcoma (RAF) and mitogen-activated protein kinase (MEPK kinase) or extracellular signal-regulated kinase (ERK kinase) (MEK) inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, which in response to previous treatment with RAF inhibitors and/or MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, which in response to previous treatment with MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative cutaneous melanoma (wild type \[WT\]), naive to any prior anticancer therapy except ipilimumab, anti-programmed cell death-1 (PD-1), and anti-PD ligand-1 (PDL-1) monoclonal antibodies.
|
Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative melanoma (WT), who had received at least 1 line of prior anticancer therapy.
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF-mutation positive cutaneous melanoma.
|
QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49), in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase
Progressive Disease
|
2
|
3
|
2
|
3
|
5
|
4
|
0
|
2
|
6
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation Phase
Adverse Event
|
2
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation Phase
Unsatisfactory Therapeutic Response
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation Phase
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation Phase
Symptomatic Deterioration
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation Phase
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion Phase
Progressive Disease
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
10
|
4
|
12
|
1
|
5
|
8
|
9
|
2
|
10
|
|
Dose Expansion Phase
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Dose Expansion Phase
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
2
|
0
|
4
|
|
Dose Expansion Phase
Symptomatic Deterioration
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
0
|
0
|
1
|
2
|
0
|
1
|
|
Dose Expansion Phase
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
3
|
3
|
0
|
1
|
1
|
5
|
0
|
3
|
|
Dose Expansion Phase
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Dose Expansion Phase
Unsatisfactory Therapeutic Response
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study of MLN2480 in Participants With Relapsed or Refractory Solid Tumors Followed by a Dose Expansion in Participants With Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle)
n=4 Participants
TAK-580 20 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle)
n=3 Participants
TAK-580 40 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle)
n=3 Participants
TAK-580 80 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle)
n=3 Participants
TAK-580 135 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle)
n=7 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle)
n=7 Participants
TAK-580 280 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle)
n=3 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)
n=3 Participants
TAK-580 400 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)
n=13 Participants
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)
n=4 Participants
TAK-580 800 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Naive)
n=16 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)
n=8 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, which in response to previous treatment with RAF inhibitors and/or MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)
n=16 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)
n=1 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, which in response to previous treatment with MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive
n=6 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative cutaneous melanoma (WT), naive to any prior anticancer therapy except ipilimumab, PD-1, and PDL-1 monoclonal antibodies.
|
Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated
n=11 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative melanoma (WT), who had received at least 1 line of prior anticancer therapy.
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
n=20 Participants
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+)
n=2 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF-mutation positive cutaneous melanoma.
|
QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive
n=19 Participants
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49), in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
71.0 years
STANDARD_DEVIATION 10.10 • n=93 Participants
|
66.3 years
STANDARD_DEVIATION 8.33 • n=4 Participants
|
56.7 years
STANDARD_DEVIATION 10.26 • n=27 Participants
|
54.7 years
STANDARD_DEVIATION 13.65 • n=483 Participants
|
58.7 years
STANDARD_DEVIATION 14.77 • n=36 Participants
|
65.0 years
STANDARD_DEVIATION 4.40 • n=10 Participants
|
71.0 years
STANDARD_DEVIATION 6.24 • n=115 Participants
|
54.7 years
STANDARD_DEVIATION 13.58 • n=40 Participants
|
57.2 years
STANDARD_DEVIATION 9.34 • n=8 Participants
|
66.8 years
STANDARD_DEVIATION 7.50 • n=62 Participants
|
54.6 years
STANDARD_DEVIATION 12.44 • n=95 Participants
|
58.9 years
STANDARD_DEVIATION 16.39 • n=129 Participants
|
68.4 years
STANDARD_DEVIATION 7.86 • n=36 Participants
|
56.0 years
STANDARD_DEVIATION NA • n=36 Participants
|
56.7 years
STANDARD_DEVIATION 17.24 • n=24 Participants
|
67.5 years
STANDARD_DEVIATION 8.69 • n=135 Participants
|
65.1 years
STANDARD_DEVIATION 14.67 • n=136 Participants
|
50.5 years
STANDARD_DEVIATION 0.71 • n=44 Participants
|
66.1 years
STANDARD_DEVIATION 11.13 • n=667 Participants
|
62.5 years
STANDARD_DEVIATION 12.47 • n=7 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
8 Participants
n=8 Participants
|
2 Participants
n=62 Participants
|
6 Participants
n=95 Participants
|
5 Participants
n=129 Participants
|
6 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
6 Participants
n=135 Participants
|
8 Participants
n=136 Participants
|
2 Participants
n=44 Participants
|
9 Participants
n=667 Participants
|
73 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=62 Participants
|
10 Participants
n=95 Participants
|
3 Participants
n=129 Participants
|
10 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
5 Participants
n=135 Participants
|
12 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
10 Participants
n=667 Participants
|
76 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
1 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
16 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
9 Participants
n=8 Participants
|
3 Participants
n=62 Participants
|
14 Participants
n=95 Participants
|
7 Participants
n=129 Participants
|
16 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
6 Participants
n=24 Participants
|
11 Participants
n=135 Participants
|
17 Participants
n=136 Participants
|
2 Participants
n=44 Participants
|
18 Participants
n=667 Participants
|
117 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
2 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
16 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
5 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
12 Participants
n=8 Participants
|
3 Participants
n=62 Participants
|
15 Participants
n=95 Participants
|
8 Participants
n=129 Participants
|
16 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
6 Participants
n=24 Participants
|
11 Participants
n=135 Participants
|
19 Participants
n=136 Participants
|
2 Participants
n=44 Participants
|
19 Participants
n=667 Participants
|
141 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
2 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
7 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
13 Participants
n=8 Participants
|
4 Participants
n=62 Participants
|
6 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
10 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=135 Participants
|
20 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
11 Participants
n=667 Participants
|
102 Participants
n=7 Participants
|
|
Region of Enrollment
United Kingdom
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
10 Participants
n=95 Participants
|
8 Participants
n=129 Participants
|
6 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
5 Participants
n=24 Participants
|
7 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
2 Participants
n=44 Participants
|
8 Participants
n=667 Participants
|
47 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after last dose, or start of subsequent therapy, whichever occurred first (up to Cycle 38 Days 52 [Q2D] and 58 [QW] [Cycle=22 days (Q2D) and 28 days (QW)] in Escalation Phase; Cycle 49 Day 58 [Cycle=28 days] in Expansion Phase)Population: The safety population included all participants who received at least 1 dose of study drug (TAK-580).
Outcome measures
| Measure |
QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)
n=3 Participants
TAK-580 400 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)
n=13 Participants
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)
n=4 Participants
TAK-580 800 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
n=16 Participants
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle)
n=4 Participants
TAK-580 20 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle)
n=3 Participants
TAK-580 40 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle)
n=3 Participants
TAK-580 80 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle)
n=3 Participants
TAK-580 135 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle)
n=7 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle)
n=7 Participants
TAK-580 280 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle)
n=3 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)
n=8 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, which in response to previous treatment with RAF inhibitors and/or MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)
n=16 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)
n=1 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, which in response to previous treatment with MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive
n=6 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative cutaneous melanoma (WT), naive to any prior anticancer therapy except ipilimumab, PD-1, and PDL-1 monoclonal antibodies.
|
Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated
n=11 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative melanoma (WT), who had received at least 1 line of prior anticancer therapy.
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
n=20 Participants
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive
n=19 Participants
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49), in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+)
n=2 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF-mutation positive cutaneous melanoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths
TEAEs
|
3 Participants
|
13 Participants
|
4 Participants
|
16 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
7 Participants
|
7 Participants
|
3 Participants
|
8 Participants
|
16 Participants
|
1 Participants
|
6 Participants
|
11 Participants
|
20 Participants
|
19 Participants
|
2 Participants
|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths
Deaths
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths
SAEs
|
2 Participants
|
5 Participants
|
3 Participants
|
9 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
6 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
11 Participants
|
8 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (Cycle length= 22 days [Q2D] and 28 days [QW])Population: The safety population included all participants who received at least 1 dose of study drug (TAK-580).
Dose limiting AEs were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. Dose limiting AEs were defined as any of the following events: Grade 4 neutropenia for more than 7 days under maximum supportive therapy; febrile neutropenia; platelet counts decreased of Grade 3 requiring platelet transfusion or blood platelet decreased of Grade 4; if Course 2 was not initiated within 14 days due to AE related to the protocol treatment; Grade 3 or higher non-hematologic toxicity that was considered clinically significant, except the following cases, Grade 3 gastrointestinal symptoms that could be controlled with supportive therapy (example, appropriate use of antiemetics, antidiarrheals), and Grade 3 or higher electrolyte abnormalities that were not deemed clinically significant.
Outcome measures
| Measure |
QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)
n=3 Participants
TAK-580 400 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)
n=13 Participants
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)
n=4 Participants
TAK-580 800 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle)
n=4 Participants
TAK-580 20 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle)
n=3 Participants
TAK-580 40 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle)
n=3 Participants
TAK-580 80 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle)
n=3 Participants
TAK-580 135 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle)
n=7 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle)
n=7 Participants
TAK-580 280 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle)
n=3 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, which in response to previous treatment with RAF inhibitors and/or MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, which in response to previous treatment with MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative cutaneous melanoma (WT), naive to any prior anticancer therapy except ipilimumab, PD-1, and PDL-1 monoclonal antibodies.
|
Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative melanoma (WT), who had received at least 1 line of prior anticancer therapy.
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49), in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF-mutation positive cutaneous melanoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase: Number of Participants With Dose-limiting Adverse Events (AEs)
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after last dose, or start of subsequent therapy, whichever occurred first (up to Cycle 38 Days 52 [Q2D] and 58 [QW] [Cycle=22 days (Q2D) and 28 days (QW)] in Escalation Phase; Cycle 49 Day 58 [Cycle=28 days] in Expansion Phase)Population: The safety population included all participants who received at least 1 dose of study drug (TAK-580).
Outcome measures
| Measure |
QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)
n=3 Participants
TAK-580 400 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)
n=13 Participants
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)
n=4 Participants
TAK-580 800 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
n=16 Participants
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle)
n=4 Participants
TAK-580 20 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle)
n=3 Participants
TAK-580 40 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle)
n=3 Participants
TAK-580 80 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle)
n=3 Participants
TAK-580 135 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle)
n=7 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle)
n=7 Participants
TAK-580 280 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle)
n=3 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)
n=8 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, which in response to previous treatment with RAF inhibitors and/or MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)
n=16 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)
n=1 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, which in response to previous treatment with MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive
n=6 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative cutaneous melanoma (WT), naive to any prior anticancer therapy except ipilimumab, PD-1, and PDL-1 monoclonal antibodies.
|
Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated
n=11 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative melanoma (WT), who had received at least 1 line of prior anticancer therapy.
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
n=20 Participants
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive
n=19 Participants
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49), in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+)
n=2 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF-mutation positive cutaneous melanoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs Related to Physical Examination Findings
Weight decreased
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Physical Examination Findings
Breath sounds abnormal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Physical Examination Findings
Weight increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to EOSV (up to Cycle 38 Days 52 [Q2D] and 58 [QW] [Cycle length =22 days (Q2D) and 28 days (QW)] in Escalation Phase; Cycle 49 Day 58 [Cycle length =28 days] in Expansion Phase)Population: The safety population included all participants who received at least 1 dose of study drug (TAK-580). Participants who were evaluable for this measure at given time point were included for the assessment.
Outcome measures
| Measure |
QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)
n=3 Participants
TAK-580 400 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)
n=13 Participants
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)
n=4 Participants
TAK-580 800 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
n=16 Participants
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle)
n=4 Participants
TAK-580 20 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle)
n=3 Participants
TAK-580 40 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle)
n=3 Participants
TAK-580 80 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle)
n=3 Participants
TAK-580 135 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle)
n=7 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle)
n=7 Participants
TAK-580 280 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle)
n=3 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)
n=8 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, which in response to previous treatment with RAF inhibitors and/or MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)
n=16 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)
n=1 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, which in response to previous treatment with MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive
n=6 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative cutaneous melanoma (WT), naive to any prior anticancer therapy except ipilimumab, PD-1, and PDL-1 monoclonal antibodies.
|
Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated
n=11 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative melanoma (WT), who had received at least 1 line of prior anticancer therapy.
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
n=20 Participants
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive
n=19 Participants
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49), in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+)
n=2 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF-mutation positive cutaneous melanoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Clinically Significant Change From Baseline in Body Weight at End of Study Visit (EOSV)
Baseline
|
73.589 kilogram (kg)
Standard Deviation 13.2534
|
81.054 kilogram (kg)
Standard Deviation 23.6907
|
80.503 kilogram (kg)
Standard Deviation 15.7401
|
95.837 kilogram (kg)
Standard Deviation 30.2887
|
87.477 kilogram (kg)
Standard Deviation 15.7794
|
72.077 kilogram (kg)
Standard Deviation 8.2162
|
67.375 kilogram (kg)
Standard Deviation 17.3371
|
77.717 kilogram (kg)
Standard Deviation 4.1695
|
76.963 kilogram (kg)
Standard Deviation 21.9026
|
77.695 kilogram (kg)
Standard Deviation 14.3247
|
69.522 kilogram (kg)
Standard Deviation 17.6937
|
71.288 kilogram (kg)
Standard Deviation 8.6570
|
81.312 kilogram (kg)
Standard Deviation 17.4736
|
57.100 kilogram (kg)
Standard Deviation NA
Standard deviation could not be calculated because only one participant was evaluable
|
75.267 kilogram (kg)
Standard Deviation 15.3231
|
72.847 kilogram (kg)
Standard Deviation 23.8439
|
79.624 kilogram (kg)
Standard Deviation 16.6098
|
83.298 kilogram (kg)
Standard Deviation 16.3695
|
67.000 kilogram (kg)
Standard Deviation NA
Standard deviation could not be calculated because only one participant was evaluable
|
|
Clinically Significant Change From Baseline in Body Weight at End of Study Visit (EOSV)
Change at EOSV
|
-1.225 kilogram (kg)
Standard Deviation 4.5746
|
-1.868 kilogram (kg)
Standard Deviation 4.8255
|
-1.270 kilogram (kg)
Standard Deviation 0.0005
|
-7.825 kilogram (kg)
Standard Deviation 20.1782
|
7.167 kilogram (kg)
Standard Deviation 16.0315
|
-1.693 kilogram (kg)
Standard Deviation 1.4468
|
1.542 kilogram (kg)
Standard Deviation 1.1139
|
-0.907 kilogram (kg)
Standard Deviation 1.3698
|
0.065 kilogram (kg)
Standard Deviation 1.4543
|
-0.544 kilogram (kg)
Standard Deviation 3.1033
|
0.272 kilogram (kg)
Standard Deviation 1.6037
|
-1.700 kilogram (kg)
Standard Deviation 6.2386
|
-3.164 kilogram (kg)
Standard Deviation 3.7607
|
—
|
-3.225 kilogram (kg)
Standard Deviation 2.9826
|
0.201 kilogram (kg)
Standard Deviation 3.7358
|
-4.292 kilogram (kg)
Standard Deviation 6.5671
|
-3.189 kilogram (kg)
Standard Deviation 3.9690
|
—
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after last dose, or start of subsequent therapy, whichever occurred first (up to Cycle 38 Days 52 [Q2D] and 58 [QW] [Cycle=22 days (Q2D) and 28 days (QW)] in Escalation Phase; Cycle 49 Day 58 [Cycle=28 days] in Expansion Phase)Population: The safety population included all participants who received at least 1 dose of study drug (TAK-580).
Outcome measures
| Measure |
QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)
n=3 Participants
TAK-580 400 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)
n=13 Participants
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)
n=4 Participants
TAK-580 800 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
n=16 Participants
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle)
n=4 Participants
TAK-580 20 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle)
n=3 Participants
TAK-580 40 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle)
n=3 Participants
TAK-580 80 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle)
n=3 Participants
TAK-580 135 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle)
n=7 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle)
n=7 Participants
TAK-580 280 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle)
n=3 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)
n=8 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, which in response to previous treatment with RAF inhibitors and/or MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)
n=16 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)
n=1 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, which in response to previous treatment with MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive
n=6 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative cutaneous melanoma (WT), naive to any prior anticancer therapy except ipilimumab, PD-1, and PDL-1 monoclonal antibodies.
|
Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated
n=11 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative melanoma (WT), who had received at least 1 line of prior anticancer therapy.
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
n=20 Participants
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive
n=19 Participants
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49), in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+)
n=2 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF-mutation positive cutaneous melanoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: at EOSV (up to Cycle 38 Days 52 [Q2D] and 58 [QW] [Cycle length =22 days (Q2D) and 28 days (QW)] in Escalation Phase; Cycle 49 Day 58 [Cycle length =28 days] in Expansion Phase)Population: The safety population included all participants who received at least 1 dose of study drug (TAK-580). Participants who were evaluable for this measure at given time point were included for the assessment.
ECOG performance score was measured on 6 point scale to assess participant's performance status, where: 0 (fully active, able to carry on all pre-disease activities without restriction); 1 (restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work); 2 (ambulatory greater than(\>) 50 percent (%) of waking hours), capable of all self-care, unable to carry out any work activities); 3 (capable of only limited self-care, confined to bed or chair \>50% of waking hours); 4(completely disabled, cannot carry on any self-care, totally confined to bed or chair); 5 (dead). A higher score indicated greater functional impairment.
Outcome measures
| Measure |
QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)
n=3 Participants
TAK-580 400 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)
n=10 Participants
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)
n=2 Participants
TAK-580 800 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
n=14 Participants
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle)
n=3 Participants
TAK-580 20 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle)
n=3 Participants
TAK-580 40 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle)
n=3 Participants
TAK-580 80 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle)
n=3 Participants
TAK-580 135 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle)
n=7 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle)
n=5 Participants
TAK-580 280 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle)
n=2 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)
n=4 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, which in response to previous treatment with RAF inhibitors and/or MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)
n=12 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, which in response to previous treatment with MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive
n=6 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative cutaneous melanoma (WT), naive to any prior anticancer therapy except ipilimumab, PD-1, and PDL-1 monoclonal antibodies.
|
Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated
n=11 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative melanoma (WT), who had received at least 1 line of prior anticancer therapy.
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
n=14 Participants
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive
n=15 Participants
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49), in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+)
n=1 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF-mutation positive cutaneous melanoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Eastern Cooperative Oncology Group (ECOG) Performance Score
|
0.7 score on a scale
Standard Deviation 0.58
|
1.0 score on a scale
Standard Deviation 0.47
|
1.0 score on a scale
Standard Deviation 0.00
|
0.7 score on a scale
Standard Deviation 0.73
|
1.0 score on a scale
Standard Deviation 0.00
|
1.0 score on a scale
Standard Deviation 1.00
|
1.7 score on a scale
Standard Deviation 1.53
|
0.3 score on a scale
Standard Deviation 0.58
|
1.3 score on a scale
Standard Deviation 0.49
|
1.2 score on a scale
Standard Deviation 0.45
|
1.0 score on a scale
Standard Deviation 0.00
|
1.5 score on a scale
Standard Deviation 0.58
|
0.6 score on a scale
Standard Deviation 0.90
|
—
|
0.8 score on a scale
Standard Deviation 0.41
|
1.2 score on a scale
Standard Deviation 0.98
|
0.6 score on a scale
Standard Deviation 0.74
|
0.7 score on a scale
Standard Deviation 0.80
|
2.0 score on a scale
Standard Deviation NA
Standard deviation could not be calculated because only one participant was evaluable
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after last dose, or start of subsequent therapy, whichever occurred first (up to Cycle 38 Days 52 [Q2D] and 58 [QW] [Cycle=22 days (Q2D) and 28 days (QW)] in Escalation Phase; Cycle 49 Day 58 [Cycle=28 days] in Expansion Phase)Population: The safety population included all participants who received at least 1 dose of study drug (TAK-580).
Outcome measures
| Measure |
QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)
n=3 Participants
TAK-580 400 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)
n=13 Participants
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)
n=4 Participants
TAK-580 800 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
n=16 Participants
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle)
n=4 Participants
TAK-580 20 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle)
n=3 Participants
TAK-580 40 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle)
n=3 Participants
TAK-580 80 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle)
n=3 Participants
TAK-580 135 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle)
n=7 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle)
n=7 Participants
TAK-580 280 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle)
n=3 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)
n=8 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, which in response to previous treatment with RAF inhibitors and/or MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)
n=16 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)
n=1 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, which in response to previous treatment with MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive
n=6 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative cutaneous melanoma (WT), naive to any prior anticancer therapy except ipilimumab, PD-1, and PDL-1 monoclonal antibodies.
|
Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated
n=11 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative melanoma (WT), who had received at least 1 line of prior anticancer therapy.
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
n=20 Participants
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive
n=19 Participants
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49), in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+)
n=2 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF-mutation positive cutaneous melanoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs Categorized Into Investigations Related to Laboratory Test of Chemistry, Hematology or Urinalysis
Liver function analyses
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With TEAEs Categorized Into Investigations Related to Laboratory Test of Chemistry, Hematology or Urinalysis
Skeletal and cardiac muscle analyses
|
0 Participants
|
0 Participants
|
0 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With TEAEs Categorized Into Investigations Related to Laboratory Test of Chemistry, Hematology or Urinalysis
Mineral and electrolyte analyses
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With TEAEs Categorized Into Investigations Related to Laboratory Test of Chemistry, Hematology or Urinalysis
Tissue enzyme analyses NEC
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With TEAEs Categorized Into Investigations Related to Laboratory Test of Chemistry, Hematology or Urinalysis
Renal function analyses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Categorized Into Investigations Related to Laboratory Test of Chemistry, Hematology or Urinalysis
Platelet analyses
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Categorized Into Investigations Related to Laboratory Test of Chemistry, Hematology or Urinalysis
White blood cell analyses
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With TEAEs Categorized Into Investigations Related to Laboratory Test of Chemistry, Hematology or Urinalysis
Red blood cell analyses
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Categorized Into Investigations Related to Laboratory Test of Chemistry, Hematology or Urinalysis
Pituitary analyses anterior
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Categorized Into Investigations Related to Laboratory Test of Chemistry, Hematology or Urinalysis
Coagulation and bleeding analyses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Categorized Into Investigations Related to Laboratory Test of Chemistry, Hematology or Urinalysis
Carbohydrate tolerance analyses (incl diabetes)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Categorized Into Investigations Related to Laboratory Test of Chemistry, Hematology or Urinalysis
Cardiac function diagnostic procedures
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Categorized Into Investigations Related to Laboratory Test of Chemistry, Hematology or Urinalysis
Digestive enzymes
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to EOSV (up to Cycle 38 Days 52 [Q2D] and 58 [QW] [Cycle length =22 days (Q2D) and 28 days (QW)] in Escalation Phase; Cycle 49 Day 58 [Cycle length =28 days] in Expansion Phase)Population: Response-evaluable population included all participants with measurable disease who received any amount of TAK-580 and had at least 1 postbaseline response assessment.
ORR was defined as the percentage of participants with complete response (CR) or partial response (PR). The ORR assessment was based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: was disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than (\<) 10 millimeter (mm). PR: was at least a 30% decrease in sum of diameter (SOD) of target lesions, taking as reference the baseline SOD.
Outcome measures
| Measure |
QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)
n=3 Participants
TAK-580 400 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)
n=8 Participants
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)
n=3 Participants
TAK-580 800 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
n=16 Participants
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle)
n=3 Participants
TAK-580 20 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle)
n=3 Participants
TAK-580 40 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle)
n=2 Participants
TAK-580 80 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle)
n=3 Participants
TAK-580 135 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle)
n=6 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle)
n=4 Participants
TAK-580 280 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle)
n=1 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)
n=6 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, which in response to previous treatment with RAF inhibitors and/or MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)
n=14 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)
n=1 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, which in response to previous treatment with MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive
n=6 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative cutaneous melanoma (WT), naive to any prior anticancer therapy except ipilimumab, PD-1, and PDL-1 monoclonal antibodies.
|
Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated
n=9 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative melanoma (WT), who had received at least 1 line of prior anticancer therapy.
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
n=14 Participants
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive
n=17 Participants
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49), in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+)
n=2 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF-mutation positive cutaneous melanoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
0 percentage of participants
|
13 percentage of participants
|
33 percentage of participants
|
50 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
17 percentage of participants
|
7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to the date of first document PD, or death due to any cause, whichever occurred first (up to Cycle 38 Days 52 [Q2D] and 58 [QW] [Cycle =22 days (Q2D) and 28 days (QW)] in Escalation Phase; Cycle 49 Day 58 [Cycle =28 days] in Expansion Phase)Population: The safety population included all participants who received at least 1 dose of study drug (TAK-580).
PFS was the time from first dose date of study drug to date of the first documentation of confirmed progressive disease (PD) or death, whichever occurred first. The PFS assessment was based on RECIST 1.1. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions. PFS was calculated using Kaplan-Meier estimate and presented with 2-sided 95% confidence interval. Participants with no response assessment were censored at the date of first dose.
Outcome measures
| Measure |
QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)
n=3 Participants
TAK-580 400 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)
n=13 Participants
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)
n=4 Participants
TAK-580 800 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
n=16 Participants
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle)
n=4 Participants
TAK-580 20 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle)
n=3 Participants
TAK-580 40 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle)
n=3 Participants
TAK-580 80 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle)
n=3 Participants
TAK-580 135 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle)
n=7 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle)
n=7 Participants
TAK-580 280 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle)
n=3 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)
n=8 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, which in response to previous treatment with RAF inhibitors and/or MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)
n=16 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)
n=1 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, which in response to previous treatment with MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive
n=6 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative cutaneous melanoma (WT), naive to any prior anticancer therapy except ipilimumab, PD-1, and PDL-1 monoclonal antibodies.
|
Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated
n=11 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative melanoma (WT), who had received at least 1 line of prior anticancer therapy.
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
n=20 Participants
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive
n=19 Participants
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49), in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+)
n=2 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF-mutation positive cutaneous melanoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
9.2 months
Interval 0.8 to 9.2
|
1.5 months
Interval 0.7 to 1.9
|
1.9 months
Interval 1.0 to
Upper limit of confidence interval could not be calculated because 75% of the participants had an event.
|
5.7 months
Interval 1.9 to 14.3
|
1.4 months
Interval 0.8 to
Upper limit of confidence interval could not be calculated because 75% of the participants had an event.
|
1.4 months
Interval 1.0 to 1.4
|
1.4 months
Interval 1.0 to 1.5
|
1.4 months
Interval 1.4 to 1.4
|
1.5 months
Interval 1.3 to 2.8
|
1.2 months
Interval 0.9 to 32.5
|
NA months
Median, lower and upper limit of confidence interval could not be calculated because no participant had an event
|
2.4 months
Interval 1.0 to 3.7
|
1.8 months
Interval 1.8 to 3.2
|
0.8 months
Confidence interval could not be calculated due to low number of events.
|
1.9 months
Interval 1.8 to 2.2
|
1.8 months
Interval 1.7 to 5.5
|
3.6 months
Interval 1.8 to
Upper limit of confidence interval could not be calculated because 50% of the participants were censored.
|
2.3 months
Interval 1.9 to 5.5
|
1.7 months
Interval 1.6 to 1.8
|
SECONDARY outcome
Timeframe: From the first documented response (CR or PR) up to the date of first documented PD (up to Cycle 38 Days 52 [Q2D] and 58 [QW] [Cycle =22 days (Q2D) and 28 days (QW)] in Escalation Phase; Cycle 49 Day 58 [Cycle =28 days] in Expansion Phase)Population: Analysis population included only a subset of participants (all responders) with response.
DOR was assessed from the first documented response (CR or PR) to the date of first documented PD and was censored at the date of the last assessment for responders who died without documented PD and for responders who were still alive and had not progressed. DOR assessment was based on RECIST v1.1. CR: was disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to \<10 mm. PR: at least 30% decrease in SOD of target lesions, taking as reference the baseline SOD persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. DOR was calculated using Kaplan-Meier estimate.
Outcome measures
| Measure |
QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)
TAK-580 400 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)
n=1 Participants
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)
n=1 Participants
TAK-580 800 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
n=8 Participants
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle)
TAK-580 20 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle)
TAK-580 40 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle)
TAK-580 80 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle)
TAK-580 135 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle)
TAK-580 200 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle)
TAK-580 280 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)
n=1 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, which in response to previous treatment with RAF inhibitors and/or MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)
n=1 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, which in response to previous treatment with MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative cutaneous melanoma (WT), naive to any prior anticancer therapy except ipilimumab, PD-1, and PDL-1 monoclonal antibodies.
|
Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative melanoma (WT), who had received at least 1 line of prior anticancer therapy.
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49), in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF-mutation positive cutaneous melanoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR)
|
—
|
NA months
Median, lower and upper limit of confidence interval could not be calculated because no participant had an event
|
NA months
Median, lower and upper limit of confidence interval could not be calculated because no participant had an event
|
6.0 months
Interval 3.7 to
Upper limit of confidence interval could not be calculated because 63% of the participants had an event
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA months
Median, lower and upper limit of confidence interval could not be calculated because no participant had an event
|
1.5 months
Confidence interval could not be calculated due to low number of events.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Escalation (Esc.) and Expansion (Exp.) Q2D: C1D1 and 21 pre-dose and at multiple time points (up to 48 hours [h]) post-dose (C=22 days [Esc. Q2D] and 28 days [Exp. Q2D]); Esc. QW: C1D1 and 22 at multiple time-points (up to168 h) post-dose (C=28 days)Population: The PK-evaluable population included all participants who had sufficient dosing data and TAK-580 concentration-time data to permit calculation of any TAK-580 parameters. PK-evaluable population where data at specified time points was available.
Outcome measures
| Measure |
QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)
n=3 Participants
TAK-580 400 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)
n=13 Participants
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)
n=4 Participants
TAK-580 800 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
n=20 Participants
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle)
n=4 Participants
TAK-580 20 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle)
n=3 Participants
TAK-580 40 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle)
n=3 Participants
TAK-580 80 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle)
n=3 Participants
TAK-580 135 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle)
n=7 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle)
n=7 Participants
TAK-580 280 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle)
n=3 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, which in response to previous treatment with RAF inhibitors and/or MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, which in response to previous treatment with MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative cutaneous melanoma (WT), naive to any prior anticancer therapy except ipilimumab, PD-1, and PDL-1 monoclonal antibodies.
|
Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative melanoma (WT), who had received at least 1 line of prior anticancer therapy.
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49), in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF-mutation positive cutaneous melanoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase and Dose Expansion Pharmacokinetic Cohort, Cmax: Maximum Observed Plasma Concentration for TAK-580
Cycle 1 Day 1
|
2934.0 nanogram per milliliter (ng/mL)
Standard Deviation 690.39
|
4459.3 nanogram per milliliter (ng/mL)
Standard Deviation 1475.08
|
6774.3 nanogram per milliliter (ng/mL)
Standard Deviation 1082.79
|
1606.9 nanogram per milliliter (ng/mL)
Standard Deviation 670.48
|
140.0 nanogram per milliliter (ng/mL)
Standard Deviation 86.61
|
393.1 nanogram per milliliter (ng/mL)
Standard Deviation 49.81
|
921.7 nanogram per milliliter (ng/mL)
Standard Deviation 332.40
|
1048.1 nanogram per milliliter (ng/mL)
Standard Deviation 290.91
|
1933.6 nanogram per milliliter (ng/mL)
Standard Deviation 717.03
|
2675.2 nanogram per milliliter (ng/mL)
Standard Deviation 1296.95
|
2072.8 nanogram per milliliter (ng/mL)
Standard Deviation 287.29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Phase and Dose Expansion Pharmacokinetic Cohort, Cmax: Maximum Observed Plasma Concentration for TAK-580
Cycle 1 Day 21
|
—
|
—
|
—
|
3548.8 nanogram per milliliter (ng/mL)
Standard Deviation 1310.21
|
301.5 nanogram per milliliter (ng/mL)
Standard Deviation 61.83
|
759.7 nanogram per milliliter (ng/mL)
Standard Deviation 138.59
|
2038.8 nanogram per milliliter (ng/mL)
Standard Deviation 1076.99
|
3321.5 nanogram per milliliter (ng/mL)
Standard Deviation 1275.83
|
3809.1 nanogram per milliliter (ng/mL)
Standard Deviation 466.85
|
4063.1 nanogram per milliliter (ng/mL)
Standard Deviation 782.33
|
4588.4 nanogram per milliliter (ng/mL)
Standard Deviation 700.04
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Phase and Dose Expansion Pharmacokinetic Cohort, Cmax: Maximum Observed Plasma Concentration for TAK-580
Cycle 1 Day 22
|
3135.2 nanogram per milliliter (ng/mL)
Standard Deviation 485.70
|
4739.8 nanogram per milliliter (ng/mL)
Standard Deviation 2902.53
|
6460.2 nanogram per milliliter (ng/mL)
Standard Deviation 1632.31
|
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: Escalation and Expansion Q2D Cohorts: C1D21 pre-dose (C=22 days [Escalation Q2D] and 28 days [Expansion Q2D]); Escalation QW Cohorts: C1D22 pre-dose (C= 28 days)Population: The PK-evaluable population included all participants who had sufficient dosing data and TAK-580 concentration-time data to permit calculation of any TAK-580 parameters. PK-evaluable population where data at specified time points was available.
Outcome measures
| Measure |
QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)
n=3 Participants
TAK-580 400 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)
n=13 Participants
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)
n=4 Participants
TAK-580 800 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
n=20 Participants
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle)
n=4 Participants
TAK-580 20 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle)
n=3 Participants
TAK-580 40 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle)
n=3 Participants
TAK-580 80 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle)
n=3 Participants
TAK-580 135 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle)
n=7 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle)
n=7 Participants
TAK-580 280 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle)
n=3 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, which in response to previous treatment with RAF inhibitors and/or MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, which in response to previous treatment with MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative cutaneous melanoma (WT), naive to any prior anticancer therapy except ipilimumab, PD-1, and PDL-1 monoclonal antibodies.
|
Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative melanoma (WT), who had received at least 1 line of prior anticancer therapy.
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49), in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF-mutation positive cutaneous melanoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase and Dose Expansion Pharmacokinetic Cohort, Ctrough: Trough Concentration for TAK-580
Cycle 1 Day 21
|
—
|
—
|
—
|
2085.0 ng/mL
Standard Deviation 672.26
|
178.3 ng/mL
Standard Deviation 42.92
|
265.5 ng/mL
Standard Deviation 74.25
|
1080.0 ng/mL
Standard Deviation 797.75
|
1720.0 ng/mL
Standard Deviation 708.87
|
1739.7 ng/mL
Standard Deviation 746.88
|
2135.0 ng/mL
Standard Deviation 494.00
|
2700.0 ng/mL
Standard Deviation 1088.94
|
—
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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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|
Dose Escalation Phase and Dose Expansion Pharmacokinetic Cohort, Ctrough: Trough Concentration for TAK-580
Cycle 1 Day 22
|
270.0 ng/mL
Standard Deviation 108.00
|
898.7 ng/mL
Standard Deviation 618.68
|
1216.7 ng/mL
Standard Deviation 841.80
|
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: Escalation (Esc.) and Expansion (Exp.) Q2D: C1D1 and 21 pre-dose and at multiple time points (up to 48 h) post-dose (C=22 days [Esc. Q2D] and 28 days [Exp. Q2D]); Esc. QW: C1D1 and 22 at multiple time-points (up to168 h) post-dose (C=28 days)Population: The PK-evaluable population included all participants who had sufficient dosing data and TAK-580 concentration-time data to permit calculation of any TAK-580 parameters. PK-evaluable population where data at specified time points was available.
Outcome measures
| Measure |
QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)
n=3 Participants
TAK-580 400 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)
n=13 Participants
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)
n=4 Participants
TAK-580 800 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
n=20 Participants
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle)
n=4 Participants
TAK-580 20 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle)
n=3 Participants
TAK-580 40 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle)
n=3 Participants
TAK-580 80 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle)
n=3 Participants
TAK-580 135 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle)
n=7 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle)
n=7 Participants
TAK-580 280 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle)
n=3 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, which in response to previous treatment with RAF inhibitors and/or MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, which in response to previous treatment with MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative cutaneous melanoma (WT), naive to any prior anticancer therapy except ipilimumab, PD-1, and PDL-1 monoclonal antibodies.
|
Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative melanoma (WT), who had received at least 1 line of prior anticancer therapy.
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49), in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF-mutation positive cutaneous melanoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase and Dose Expansion Pharmacokinetic Cohort, Tmax: Time to Reach the Cmax for TAK-580
Cycle 1 Day 22
|
3.150 hour
Interval 2.8 to 3.17
|
3.033 hour
Interval 2.1 to 23.8
|
3.950 hour
Interval 2.87 to 7.32
|
—
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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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—
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—
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—
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—
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—
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—
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|
Dose Escalation Phase and Dose Expansion Pharmacokinetic Cohort, Tmax: Time to Reach the Cmax for TAK-580
Cycle 1 Day 1
|
4.150 hour
Interval 3.2 to 5.12
|
3.150 hour
Interval 1.0 to 7.88
|
3.100 hour
Interval 2.12 to 7.27
|
3.108 hour
Interval 0.98 to 7.58
|
3.983 hour
Interval 2.0 to 4.07
|
2.150 hour
Interval 1.98 to 4.05
|
2.033 hour
Interval 2.0 to 4.0
|
3.917 hour
Interval 1.18 to 4.02
|
2.050 hour
Interval 1.0 to 23.82
|
4.033 hour
Interval 0.97 to 23.0
|
4.000 hour
Interval 1.98 to 6.02
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Phase and Dose Expansion Pharmacokinetic Cohort, Tmax: Time to Reach the Cmax for TAK-580
Cycle 1 Day 21
|
—
|
—
|
—
|
2.192 hour
Interval 1.87 to 6.17
|
2.000 hour
Interval 2.0 to 4.0
|
3.050 hour
Interval 2.1 to 4.0
|
4.050 hour
Interval 2.0 to 6.12
|
2.000 hour
Interval 1.0 to 2.0
|
2.992 hour
Interval 1.0 to 8.0
|
2.808 hour
Interval 1.98 to 4.0
|
12.792 hour
Interval 2.13 to 23.45
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Escalation (Esc.) and Expansion (Exp.) Q2D: C1D21 pre-dose and at multiple time points (up to 48 h) post-dose (C=22 days [Esc. Q2D] and 28 days [Exp. Q2D]); Esc. QW: C1D22 at multiple time-points (up to168 h) post-dose (C=28 days)Population: PK-evaluable population. t1/2z of TAK-580 could not be determined in cancer participants who were on Q2D regimen with a 48-hour dose interval since the duration of plasma PK sample collection within the dose interval was shorter than the anticipated t1/2z of TAK-580. PK-evaluable population where data at specified time points was available.
Outcome measures
| Measure |
QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)
n=3 Participants
TAK-580 400 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)
n=6 Participants
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)
n=3 Participants
TAK-580 800 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle)
TAK-580 20 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle)
TAK-580 40 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle)
TAK-580 80 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle)
TAK-580 135 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle)
TAK-580 200 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle)
TAK-580 280 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, which in response to previous treatment with RAF inhibitors and/or MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, which in response to previous treatment with MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative cutaneous melanoma (WT), naive to any prior anticancer therapy except ipilimumab, PD-1, and PDL-1 monoclonal antibodies.
|
Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative melanoma (WT), who had received at least 1 line of prior anticancer therapy.
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49), in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF-mutation positive cutaneous melanoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase and Dose Expansion Pharmacokinetic Cohort, t1/2z: Terminal Phase Disposition Half-life for TAK-580
Cycle 1 Day 22
|
50.22 hour
Interval 46.4 to 59.3
|
59.06 hour
Interval 31.1 to 119.2
|
69.65 hour
Interval 61.6 to 73.0
|
—
|
—
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—
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—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Q2D Cohorts: Cycle1 Days 1 and 21 up to 24 hours post-dose (Cycle1 length= 22 days); QW Cohorts: Cycle2 Days 1 and 22 up to 7 hours post-dose (Cycle 2 length= 28 days)Population: CLr of TAK-580 could not be determined since urine samples were collected for a limited duration during a site visit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 Days 1 and 21 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length= 22 days)Population: The PK-evaluable population included all participants who had sufficient dosing data and TAK-580 concentration-time data to permit calculation of any TAK-580 parameters. PK-evaluable population where data at specified time points was available.
Outcome measures
| Measure |
QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)
n=20 Participants
TAK-580 400 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)
TAK-580 800 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle)
n=4 Participants
TAK-580 20 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle)
n=3 Participants
TAK-580 40 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle)
n=3 Participants
TAK-580 80 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle)
n=3 Participants
TAK-580 135 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle)
n=7 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle)
n=7 Participants
TAK-580 280 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle)
n=3 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, which in response to previous treatment with RAF inhibitors and/or MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, which in response to previous treatment with MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative cutaneous melanoma (WT), naive to any prior anticancer therapy except ipilimumab, PD-1, and PDL-1 monoclonal antibodies.
|
Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative melanoma (WT), who had received at least 1 line of prior anticancer therapy.
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49), in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF-mutation positive cutaneous melanoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Q2D Dose Escalation Phase and Q2D Dose Expansion Pharmacokinetic Cohort, AUC(0-48): Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Postdose for TAK-580
Day 21
|
127026.4 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 38244.03
|
—
|
—
|
—
|
10679.2 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 2571.83
|
21007.9 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 3501.86
|
43294.2 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 10403.72
|
99626.7 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 29090.62
|
125540.2 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 46299.79
|
156439.3 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 26263.33
|
165002.1 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 19899.97
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Q2D Dose Escalation Phase and Q2D Dose Expansion Pharmacokinetic Cohort, AUC(0-48): Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Postdose for TAK-580
Day 1
|
53522.2 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 17337.54
|
—
|
—
|
—
|
4799.7 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 2570.95
|
11019.7 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 655.03
|
30562.8 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 16909.20
|
36061.9 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 8904.40
|
50946.5 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 10597.12
|
78993.3 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 23713.60
|
66799.2 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 7656.58
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Days 1 and 22 pre-dose and at multiple time points (up to 168 hours) post-dose (Cycle length= 28 days)Population: The PK-evaluable population included all participants who had sufficient dosing data and TAK-580 concentration-time data to permit calculation of any TAK-580 parameters. PK-evaluable population where data at specified time points was available.
Outcome measures
| Measure |
QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)
TAK-580 400 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)
TAK-580 800 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle)
n=3 Participants
TAK-580 20 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle)
n=13 Participants
TAK-580 40 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle)
n=4 Participants
TAK-580 80 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle)
TAK-580 135 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle)
TAK-580 200 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle)
TAK-580 280 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, which in response to previous treatment with RAF inhibitors and/or MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, which in response to previous treatment with MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative cutaneous melanoma (WT), naive to any prior anticancer therapy except ipilimumab, PD-1, and PDL-1 monoclonal antibodies.
|
Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative melanoma (WT), who had received at least 1 line of prior anticancer therapy.
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49), in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF-mutation positive cutaneous melanoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
QW Dose Escalation Phase, AUC(0-168): Area Under the Plasma Concentration-time Curve From Time 0 to 168 Hours Postdose for TAK-580
Day 1
|
—
|
—
|
—
|
—
|
184534.4 h*ng/mL
Standard Deviation 50225.97
|
278247.9 h*ng/mL
Standard Deviation 128772.92
|
431723.3 h*ng/mL
Standard Deviation 106266.40
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
QW Dose Escalation Phase, AUC(0-168): Area Under the Plasma Concentration-time Curve From Time 0 to 168 Hours Postdose for TAK-580
Day 22
|
—
|
—
|
—
|
—
|
199210.4 h*ng/mL
Standard Deviation 57957.62
|
339244.8 h*ng/mL
Standard Deviation 149201.72
|
477700.2 h*ng/mL
Standard Deviation 86620.19
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Cycle 1 Day 21 (Q2D), and Cycle 1 Day 22 (QW) (Cycle length= 22 days [Q2D] and 28 days [QW])Population: Pharmacodynamic (PD)-evaluable: all participants who had sufficient dosing and PD data,collected within protocol-specified window of sampling time.Participants who were evaluable for this measure at given time point were included. Data for this measure was not planned to be collected and analyzed for Q2D Dose Expansion Phase:Pharmacokinetic Cohort.
The extent of phosphorylated extracellular signal-regulated kinase (pERK) staining was assessed in the melanoma expansion cohorts. The level of staining was assessed by a pathologist (semi-H scores) and by quantified image analysis (quant H-scores). The H-score scale used to interpret data from the pathologist rating was as follows: 0 to 99 =low staining; 100 to 199= medium staining; 200 to 300 =high staining. The H-score scale used to interpret data from the quantified image analysis was as followed: 0 to 100 =low staining; 100 to 150= medium staining; 150 to 235= high staining.
Outcome measures
| Measure |
QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)
n=1 Participants
TAK-580 400 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)
TAK-580 800 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle)
n=3 Participants
TAK-580 20 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle)
n=4 Participants
TAK-580 40 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle)
n=6 Participants
TAK-580 80 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle)
TAK-580 135 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle)
n=2 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle)
n=5 Participants
TAK-580 280 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle)
n=3 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, which in response to previous treatment with RAF inhibitors and/or MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, which in response to previous treatment with MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative cutaneous melanoma (WT), naive to any prior anticancer therapy except ipilimumab, PD-1, and PDL-1 monoclonal antibodies.
|
Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative melanoma (WT), who had received at least 1 line of prior anticancer therapy.
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49), in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF-mutation positive cutaneous melanoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Phase, Melanoma Cohorts: Percent Change From Baseline in RAF Inhibition Biomarkers at Specified Time Points
Quant H-score
|
-71.0 percent change
Interval -71.0 to -71.0
|
—
|
—
|
—
|
180.0 percent change
Interval -100.0 to 460.0
|
-93.5 percent change
Interval -97.0 to 1235.0
|
-82.0 percent change
Interval -96.0 to -43.0
|
—
|
-51.0 percent change
Interval -97.0 to -5.0
|
-15.0 percent change
Interval -95.0 to 22.0
|
-8.0 percent change
Interval -8.0 to -8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Phase, Melanoma Cohorts: Percent Change From Baseline in RAF Inhibition Biomarkers at Specified Time Points
Semi H-score
|
-23.0 percent change
Interval -23.0 to -23.0
|
—
|
—
|
—
|
-94.5 percent change
Interval -100.0 to -89.0
|
-80.5 percent change
Interval -100.0 to 2207.0
|
-70.0 percent change
Interval -100.0 to 603.0
|
—
|
-24.5 percent change
Interval -78.0 to 29.0
|
-27.0 percent change
Interval -100.0 to 0.0
|
-12.0 percent change
Interval -12.0 to -12.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Cycle 1 Day 21 (Q2D), and Cycle 1 Day 22 (QW) (Cycle length= 22 days [Q2D] and 28 days [QW])Population: PD-evaluable: all participants who had sufficient dosing and PD data, collected within protocol-specified window of sampling time. Participants who were evaluable for this measure at given time point were included. Data for this measure was not planned to be collected and analyzed for Q2D Dose Expansion Phase: Pharmacokinetic Cohort.
The extent of cleaved poly ADP-ribose polymerase (cPARP) and BIM-1 was assessed in the melanoma expansion cohorts. The level of staining was assessed by quantified image analysis (quant H-scores) and by quantified image analysis (quant H-scores). The H-score scale used to interpret data from the pathologist rating was as follows: 0 to 99= low staining; 100 to 199 =medium staining; 200 to 300 =high staining. The H-score scale used to interpret data from the quantified image analysis was as followed in cPARP: 0 to 70= low staining; 70 to 175 =medium staining; 175 to 240 =high staining; BIM-1: 0 to 128= low staining; 128 to 155 =medium staining; 155 to 229 =high staining.
Outcome measures
| Measure |
QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)
n=1 Participants
TAK-580 400 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)
TAK-580 800 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle)
n=3 Participants
TAK-580 20 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle)
n=4 Participants
TAK-580 40 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle)
n=6 Participants
TAK-580 80 mg, tablet, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle)
TAK-580 135 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle)
n=2 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle)
n=5 Participants
TAK-580 280 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle)
n=3 Participants
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, which in response to previous treatment with RAF inhibitors and/or MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, which in response to previous treatment with MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative cutaneous melanoma (WT), naive to any prior anticancer therapy except ipilimumab, PD-1, and PDL-1 monoclonal antibodies.
|
Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative melanoma (WT), who had received at least 1 line of prior anticancer therapy.
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49), in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+)
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF-mutation positive cutaneous melanoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Phase, Melanoma Cohorts: Percent Change From Baseline in Apoptotic Biomarkers at Specified Time Points
BIM-1 Quant H-score
|
960.0 percent change
Interval 960.0 to 960.0
|
—
|
—
|
—
|
265.0 percent change
Interval 265.0 to 265.0
|
136.0 percent change
Interval 64.0 to 650.0
|
158.0 percent change
Interval 90.0 to 625.0
|
—
|
-52.5 percent change
Interval -65.0 to -40.0
|
-23.5 percent change
Interval -53.0 to 66.0
|
35.5 percent change
Interval -29.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Phase, Melanoma Cohorts: Percent Change From Baseline in Apoptotic Biomarkers at Specified Time Points
BIM-1 Semi H-score
|
—
|
—
|
—
|
—
|
723.5 percent change
Interval 47.0 to 1400.0
|
64.5 percent change
Interval -84.0 to 2533.0
|
64.0 percent change
Interval 30.0 to 287.0
|
—
|
-41.0 percent change
Interval -75.0 to -7.0
|
-17.0 percent change
Interval -49.0 to 28.0
|
-3.5 percent change
Interval -15.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Phase, Melanoma Cohorts: Percent Change From Baseline in Apoptotic Biomarkers at Specified Time Points
cPARP Quant H-score
|
—
|
—
|
—
|
—
|
—
|
-100.0 percent change
Interval -100.0 to -93.0
|
317.5 percent change
Interval -15.0 to 650.0
|
—
|
-100.0 percent change
Interval -100.0 to -100.0
|
-33.5 percent change
Interval -100.0 to 200.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Phase, Melanoma Cohorts: Percent Change From Baseline in Apoptotic Biomarkers at Specified Time Points
cPARP Semi H-score
|
—
|
—
|
—
|
—
|
—
|
-96.0 percent change
Interval -100.0 to -92.0
|
-33.0 percent change
Interval -33.0 to -33.0
|
—
|
-11.0 percent change
Interval -11.0 to -11.0
|
-48.0 percent change
Interval -100.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle)
Serious events: 4 serious events
Other events: 7 other events
Deaths: 1 deaths
Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)
Serious events: 5 serious events
Other events: 12 other events
Deaths: 2 deaths
QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Naive)
Serious events: 9 serious events
Other events: 16 other events
Deaths: 0 deaths
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)
Serious events: 6 serious events
Other events: 8 other events
Deaths: 2 deaths
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)
Serious events: 5 serious events
Other events: 16 other events
Deaths: 2 deaths
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
Serious events: 11 serious events
Other events: 19 other events
Deaths: 1 deaths
Q2D Dose Expansion Phase: TAK-580 (BRAF+)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive
Serious events: 8 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle)
n=4 participants at risk
TAK-580 20 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cy cle 38).
|
Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle)
n=3 participants at risk
TAK-580 40 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle)
n=3 participants at risk
TAK-580 80 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle)
n=3 participants at risk
TAK-580 135 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle)
n=7 participants at risk
TAK-580 200 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle)
n=7 participants at risk
TAK-580 280 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle)
n=3 participants at risk
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)
n=3 participants at risk
TAK-580 400 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)
n=13 participants at risk
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)
n=4 participants at risk
TAK-580 800 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Naive)
n=16 participants at risk
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)
n=8 participants at risk
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, which in response to previous treatment with RAF inhibitors and/or MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)
n=16 participants at risk
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)
n=1 participants at risk
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, which in response to previous treatment with MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive
n=6 participants at risk
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative cutaneous melanoma (WT), naive to any prior anticancer therapy except ipilimumab, PD-1, and PDL-1 monoclonal antibodies.
|
Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated
n=11 participants at risk
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative melanoma (WT), who had received at least 1 line of prior anticancer therapy.
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
n=20 participants at risk
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+)
n=2 participants at risk
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF-mutation positive cutaneous melanoma.
|
QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive
n=19 participants at risk
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49), in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Diverticulitis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
23.1%
3/13 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.5%
2/19 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
25.0%
1/4 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • Number of events 11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.5%
2/19 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Infection
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Peripheral swelling
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle)
n=4 participants at risk
TAK-580 20 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cy cle 38).
|
Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle)
n=3 participants at risk
TAK-580 40 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle)
n=3 participants at risk
TAK-580 80 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle)
n=3 participants at risk
TAK-580 135 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle)
n=7 participants at risk
TAK-580 200 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle)
n=7 participants at risk
TAK-580 280 mg, tablets, orally, Q2D, in each 22-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle)
n=3 participants at risk
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle)
n=3 participants at risk
TAK-580 400 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle)
n=13 participants at risk
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle)
n=4 participants at risk
TAK-580 800 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 38).
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Naive)
n=16 participants at risk
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+ Previously Treated)
n=8 participants at risk
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF mutation-positive cutaneous melanoma, which in response to previous treatment with RAF inhibitors and/or MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Naive)
n=16 participants at risk
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
Q2D Dose Expansion Phase: TAK-580 (NRAS+ Previously Treated)
n=1 participants at risk
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with NRAS mutation-positive cutaneous melanoma, which in response to previous treatment with MEK inhibitors had relapsed following an objective response, failed to demonstrate an objective response and/or could not tolerate such a regimen due to unacceptable toxicity.
|
Q2D Dose Expansion Phase: TAK-580 BRAF/NRAS WT+ Naive
n=6 participants at risk
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative cutaneous melanoma (WT), naive to any prior anticancer therapy except ipilimumab, PD-1, and PDL-1 monoclonal antibodies.
|
Q2D Dose Expansion Phase:TAK-580 BRAF/NRASWT+PreviouslyTreated
n=11 participants at risk
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF/NRAS mutation-negative melanoma (WT), who had received at least 1 line of prior anticancer therapy.
|
Q2D Dose Expansion Phase: Pharmacokinetic Cohort
n=20 participants at risk
TAK-580 200 mg, tablets, orally, on Days 1 through 21 in a 28-days treatment Cycle 1, followed by TAK-580 200 mg, tablets, orally, Q2D in each 28-days treatment cycle from Cycle 2 until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with any advanced solid tumor (excluding lymphoma, but including melanoma) who had failed or were not candidates for standard therapies or for whom no approved therapy was available.
|
Q2D Dose Expansion Phase: TAK-580 (BRAF+)
n=2 participants at risk
TAK-580 200 mg, tablets, orally, Q2D, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49) in participants with BRAF-mutation positive cutaneous melanoma.
|
QW Dose Expansion Phase: TAK-580 NRAS WT+ Naive
n=19 participants at risk
TAK-580 600 mg, tablets, orally, QW, in each 28-days treatment cycle until disease progression, unacceptable toxicity, or participant discontinuation for any other reason (up to Cycle 49), in participants with NRAS mutation-positive cutaneous melanoma, naive to prior therapy with RAF and MEK inhibitors.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.4%
2/13 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
2/4 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
27.3%
3/11 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
4/20 • Number of events 9 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.8%
3/19 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
3/3 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
42.9%
3/7 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
30.8%
4/13 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
75.0%
12/16 • Number of events 42 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
87.5%
7/8 • Number of events 23 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
56.2%
9/16 • Number of events 11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
3/6 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
30.0%
6/20 • Number of events 10 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
21.1%
4/19 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
38.5%
5/13 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
31.2%
5/16 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
31.2%
5/16 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
55.0%
11/20 • Number of events 15 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
2/2 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
26.3%
5/19 • Number of events 6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.4%
2/13 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.8%
3/16 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.8%
3/16 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
5/20 • Number of events 6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.4%
2/13 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
2/4 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.0%
3/20 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.8%
3/16 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.8%
3/16 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
4/20 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
37.5%
3/8 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.8%
3/19 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
30.8%
4/13 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
4/4 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.8%
3/16 • Number of events 8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.5%
2/19 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Salivary gland pain
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
75.0%
3/4 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
66.7%
2/3 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
85.7%
6/7 • Number of events 8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
85.7%
6/7 • Number of events 7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
3/3 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
46.2%
6/13 • Number of events 7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
2/4 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
31.2%
5/16 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
37.5%
3/8 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
43.8%
7/16 • Number of events 8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
3/6 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
27.3%
3/11 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
60.0%
12/20 • Number of events 13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
47.4%
9/19 • Number of events 12 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
66.7%
2/3 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
23.1%
3/13 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.8%
3/16 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
35.0%
7/20 • Number of events 9 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.4%
2/13 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
43.8%
7/16 • Number of events 9 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
2/2 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.8%
3/19 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Face oedema
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
42.9%
3/7 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
42.9%
3/7 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
4/20 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chills
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
42.9%
3/7 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.0%
3/20 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chest pain
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.8%
3/16 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pain
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Peripheral swelling
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chest discomfort
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Localised oedema
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Oedema
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Axillary pain
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Catheter site pain
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Facial pain
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Feeling cold
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site bruising
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Malaise
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
66.7%
2/3 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
57.1%
4/7 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
66.7%
2/3 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.4%
2/13 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
43.8%
7/16 • Number of events 11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
37.5%
3/8 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
56.2%
9/16 • Number of events 18 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
35.0%
7/20 • Number of events 9 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.5%
2/19 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
66.7%
2/3 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
23.1%
3/13 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
37.5%
3/8 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
4/16 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
4/20 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
4/16 • Number of events 8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.0%
3/20 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.5%
2/19 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
37.5%
6/16 • Number of events 7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.8%
3/16 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.0%
3/20 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.5%
2/19 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
4/16 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.5%
2/19 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.0%
3/20 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.4%
2/13 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Madarosis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Butterfly rash
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Livedo reticularis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin plaque
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
66.7%
2/3 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
66.7%
2/3 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.4%
2/13 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.8%
3/16 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
45.0%
9/20 • Number of events 9 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.8%
3/19 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
2/4 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
66.7%
2/3 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
66.7%
2/3 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
23.1%
3/13 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.8%
3/16 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
4/20 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
21.1%
4/19 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.8%
3/16 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
27.3%
3/11 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.4%
2/13 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.8%
3/16 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
27.3%
3/11 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.0%
3/20 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.8%
3/16 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
8/16 • Number of events 13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
45.5%
5/11 • Number of events 7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
30.0%
6/20 • Number of events 10 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
4/16 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
5/20 • Number of events 8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
2/2 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
27.3%
3/11 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.5%
2/19 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.4%
2/13 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.5%
2/19 • Number of events 6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
4/20 • Number of events 7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.0%
3/20 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood calcium decreased
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.0%
3/20 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Weight increased
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.0%
3/20 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.0%
3/20 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood folate decreased
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood potassium increased
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Lipase increased
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
White blood cell count increased
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
38.5%
5/13 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
4/16 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.5%
2/19 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
31.2%
5/16 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
37.5%
3/8 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
27.3%
3/11 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.0%
3/20 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.0%
3/20 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
37.5%
6/16 • Number of events 8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.8%
3/16 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
45.0%
9/20 • Number of events 10 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.5%
2/19 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.8%
3/16 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
5/20 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.5%
2/19 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.4%
2/13 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
2/2 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Restrictive pulmonary disease
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
66.7%
2/3 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.8%
3/16 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
4/16 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
21.1%
4/19 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
23.1%
3/13 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
27.3%
3/11 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
66.7%
2/3 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
30.8%
4/13 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
75.0%
3/4 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
31.2%
5/16 • Number of events 7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
43.8%
7/16 • Number of events 9 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
45.5%
5/11 • Number of events 9 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
45.0%
9/20 • Number of events 13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
2/2 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
21.1%
4/19 • Number of events 5 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Reticulocytosis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.8%
3/16 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Lung infection
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Candida infection
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Ear lobe infection
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Genital infection
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Paronychia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
4/16 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
27.3%
3/11 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.0%
3/20 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.5%
2/19 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Eye swelling
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
2/16 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.8%
3/16 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Eyelash discolouration
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Eye irritation
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
43.8%
7/16 • Number of events 19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
37.5%
3/8 • Number of events 4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Eyelid disorder
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Eyelid irritation
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Eyelids pruritus
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Optic nerve disorder
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Photophobia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Scleral haemorrhage
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.5%
2/19 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Haematoma
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.0%
3/20 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.5%
2/19 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
21.1%
4/19 • Number of events 6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.4%
2/13 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Conjunctival abrasion
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Stoma site pain
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
50.0%
2/4 • Number of events 3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to chest wall
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Ear and labyrinth disorders
Ear disorder
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Breast oedema
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Number of events 1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (approximately Cycle 38 Days 52 [Q2D] and 58 [QW] in Escalation Phase; Cycle 49 Day 58 in Expansion Phase)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER