Trial Outcomes & Findings for A Phase I Study of Oral LGX818 in Adult Patients With Advanced or Metastatic BRAF Mutant Melanoma (NCT NCT01436656)
NCT ID: NCT01436656
Last Updated: 2024-10-28
Results Overview
DLT= Adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within first 28 days of treatment with encorafenib and met any of following criteria: \>=grade (G)3 neutropenia or thrombocytopenia for \>7 days; G4 thrombocytopenia; febrile neutropenia; \>=G3 serum creatinine, blood bilirubin; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) and lipase and/or serum amylase (\>=G3 for \> 7 consecutive days or G4); \>=G3 ALT or AST and \>=G2 blood bilirubin; \>=G3 persistent hypertension with more than one drug or more intensive therapy or cardiac disorders or AE excluding on-target side-effect that is manageable; G3 fatigue/asthenia for \>7 consecutive days; \>= G3 vomiting or nausea or diarrhea lasting more than 48 hours despite treatment; \>=G3 pancreatitis, rash/photosensitivity (G3 for \> 7 consecutive days despite skin toxicity treatment or G4); G3 or G4 eye disorders.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
107 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2024-10-28
Participant Flow
A total of 107 participants (54 in dose escalation and 53 in dose expansion) were enrolled in this study.
Participant milestones
| Measure |
50 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib (LGX818) orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Mel Naive 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Mel Naive 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Mel Pre-treated: 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Mel Pre-treated: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Mel Stepwise: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
|
Metastatic Colorectal Cancer: 300 mg Encorafenib
Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
|
Metastatic Colorectal Cancer: 450 mg Encorafenib
Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation
STARTED
|
4
|
10
|
6
|
3
|
5
|
4
|
4
|
5
|
6
|
5
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation
COMPLETED
|
1
|
6
|
5
|
3
|
1
|
2
|
3
|
2
|
4
|
3
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation
NOT COMPLETED
|
3
|
4
|
1
|
0
|
4
|
2
|
1
|
3
|
2
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
6
|
2
|
16
|
2
|
6
|
12
|
|
Dose Expansion
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
1
|
8
|
2
|
2
|
4
|
|
Dose Expansion
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
6
|
1
|
8
|
0
|
4
|
8
|
Reasons for withdrawal
| Measure |
50 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib (LGX818) orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Mel Naive 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Mel Naive 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Mel Pre-treated: 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Mel Pre-treated: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Mel Stepwise: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
|
Metastatic Colorectal Cancer: 300 mg Encorafenib
Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
|
Metastatic Colorectal Cancer: 450 mg Encorafenib
Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation
Death
|
1
|
3
|
1
|
0
|
2
|
1
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
2
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation
Administrative problems
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation
Lost to Follow-up
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation
New anti-cancer therapy
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
3
|
1
|
2
|
0
|
1
|
1
|
|
Dose Expansion
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
3
|
0
|
3
|
3
|
|
Dose Expansion
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Dose Expansion
Disease progression
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
0
|
1
|
0
|
0
|
1
|
|
Dose Expansion
New cancer therapy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
2
|
0
|
0
|
0
|
Baseline Characteristics
A Phase I Study of Oral LGX818 in Adult Patients With Advanced or Metastatic BRAF Mutant Melanoma
Baseline characteristics by cohort
| Measure |
50 mg of Encorafenib QD
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 mg encorafenib (LGX818) orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity
|
100 mg Encorafenib QD
n=10 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Mel Naive 300 mg Encorafenib
n=9 Participants
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Mel Naive 450 mg Encorafenib
n=6 Participants
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Mel Pre-treated: 300 mg Encorafenib
n=2 Participants
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Mel Pre-treated: 450 mg Encorafenib
n=16 Participants
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Mel Stepwise: 450 mg Encorafenib
n=2 Participants
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
|
Metastatic Colorectal Cancer: 300 mg Encorafenib
n=6 Participants
Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
|
Metastatic Colorectal Cancer: 450 mg Encorafenib
n=12 Participants
Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
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
|
|
Age, Customized
Between 18 and 44 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
7 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
27 Participants
n=667 Participants
|
|
Age, Customized
Between 45 and 64 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
4 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
4 Participants
n=136 Participants
|
7 Participants
n=44 Participants
|
51 Participants
n=667 Participants
|
|
Age, Customized
>=65 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
5 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
4 Participants
n=44 Participants
|
29 Participants
n=667 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
13 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
7 Participants
n=44 Participants
|
48 Participants
n=667 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
5 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
5 Participants
n=44 Participants
|
59 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
5 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
16 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
6 Participants
n=136 Participants
|
12 Participants
n=44 Participants
|
100 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
Others
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
7 Participants
n=667 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: Dose-Determining Set (DDS) consisted of all participants from the safety set who either met the following minimum exposure (received at least 75% of the planned doses of encorafenib in Cycle 1; observed for at least 1 cycle and considered to have sufficient safety data to conclude that a DLT did not occur in cycle 1) and had completed scheduled safety evaluations or experienced a DLT.
DLT= Adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within first 28 days of treatment with encorafenib and met any of following criteria: \>=grade (G)3 neutropenia or thrombocytopenia for \>7 days; G4 thrombocytopenia; febrile neutropenia; \>=G3 serum creatinine, blood bilirubin; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) and lipase and/or serum amylase (\>=G3 for \> 7 consecutive days or G4); \>=G3 ALT or AST and \>=G2 blood bilirubin; \>=G3 persistent hypertension with more than one drug or more intensive therapy or cardiac disorders or AE excluding on-target side-effect that is manageable; G3 fatigue/asthenia for \>7 consecutive days; \>= G3 vomiting or nausea or diarrhea lasting more than 48 hours despite treatment; \>=G3 pancreatitis, rash/photosensitivity (G3 for \> 7 consecutive days despite skin toxicity treatment or G4); G3 or G4 eye disorders.
Outcome measures
| Measure |
50 mg Encorafenib QD
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
n=9 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose-Limiting Toxicity (DLT) During Dose Escalation Phase
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: DDS consisted of all participants from the safety set who either met the following minimum exposure criterion (received at least 75% of the planned doses of encorafenib in Cycle 1; observed for at least 1 cycle and considered to have sufficient safety data to conclude that a DLT did not occur in cycle 1) and had completed scheduled safety evaluations or experienced a DLT.
DLT= Adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within first 28 days of treatment with encorafenib and met any of following criteria: \>=grade (G)3 neutropenia or thrombocytopenia for \>7 days; G4 thrombocytopenia; febrile neutropenia; \>=G3 serum creatinine, blood bilirubin; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) and lipase and/or serum amylase (\>=G3 for \> 7 consecutive days or G4); \>=G3 ALT or AST and \>=G2 blood bilirubin; \>=G3 persistent hypertension with more than one drug or more intensive therapy or cardiac disorders or AE excluding on-target side-effect that is manageable; G3 fatigue/asthenia for \>7 consecutive days; \>= G3 vomiting or nausea or diarrhea lasting more than 48 hours despite treatment; \>=G3 pancreatitis, rash/photosensitivity (G3 for \> 7 consecutive days despite skin toxicity treatment or G4); G3 or G4 eye disorders.
Outcome measures
| Measure |
50 mg Encorafenib QD
n=9 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=13 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
n=12 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With DLT During Dose Expansion Phase
|
2 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure)Population: Safety set included all participants who received at least one dose of encorafenib and had at least one valid post-baseline safety assessment.
An AE was defined as the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions. An SAE was defined as one of the following: fatal or life-threatening; resulted in significant disability/incapacity; congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization unless for routine treatment, elective or pre-planned treatment for a pre-existing condition, treatment on an emergency outpatient basis, social reasons and respite care in the absence of any deterioration in the participants general condition, any SAEs that were expected due to the condition being treated.
Outcome measures
| Measure |
50 mg Encorafenib QD
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
n=10 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) During Dose Escalation Phase
Adverse Events (AEs)
|
4 Participants
|
10 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) During Dose Escalation Phase
Serious Adverse Events (SAEs)
|
3 Participants
|
7 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment until 30 days after last dose of study treatment (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)Population: Safety set included all participants who received at least one dose of encorafenib and had at least one valid post-baseline safety assessment.
An AE was defined as the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions. An SAE was defined as one of the following: fatal or life-threatening; resulted in significant disability/incapacity; congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization unless for routine treatment, elective or pre-planned treatment for a pre-existing condition, treatment on an emergency outpatient basis, social reasons and respite care in the absence of any deterioration in the participants general condition, any SAEs that were expected due to the condition being treated.
Outcome measures
| Measure |
50 mg Encorafenib QD
n=9 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=16 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
n=12 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With AEs and SAEs During Dose Expansion Phase
Adverse Events (AEs)
|
9 Participants
|
6 Participants
|
2 Participants
|
16 Participants
|
2 Participants
|
6 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With AEs and SAEs During Dose Expansion Phase
Serious Adverse Events (SAEs)
|
2 Participants
|
4 Participants
|
2 Participants
|
9 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment until first documentation of PD or death due to any cause or censoring date (maximum of 556.1 weeks of treatment exposure)Population: Full Analysis Set (FAS) included all participants who received at least one dose of encorafenib.
PFS was defined as time from date of first study treatment intake to date of first documented disease progression (PD) or death due to any cause. If a participant did not have an event, data censoring was done at the date of last adequate tumor assessment. PD was defined for target disease as at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study (this included baseline sum if that was smallest on study), sum also demonstrated absolute increase of greater than or equal to (\>=) 5 mm, or appearance of \>=1 new lesions. For non-target disease: PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion was also considered PD. Analysis was performed using Kaplan-Meier method.
Outcome measures
| Measure |
50 mg Encorafenib QD
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
n=10 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS): Dose Escalation Phase
|
75.0 Months
Interval 19.4 to 99.4
|
10.0 Months
Interval 0.3 to 44.5
|
50.0 Months
Interval 11.8 to 88.2
|
33.3 Months
Interval 0.8 to 90.6
|
50.0 Months
Interval 6.8 to 93.2
|
40.0 Months
Interval 5.3 to 85.3
|
0.0 Months
Interval 0.0 to 52.2
|
75.0 Months
Interval 19.4 to 99.4
|
33.3 Months
Interval 4.3 to 77.7
|
20.0 Months
Interval 0.5 to 71.6
|
0.0 Months
Interval 0.0 to 84.2
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment until first documentation of PD or death due to any cause or censoring date (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)Population: FAS included all participants who received at least one dose of encorafenib.
PFS was defined as time from date of first study treatment intake to date of first documented PD or death due to any cause. If a participant did not have an event, data censoring was done at the date of last adequate tumor assessment. PD was defined for target disease as at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study (this included baseline sum if that was smallest on study), sum also demonstrated absolute increase of \>= 5 mm, or appearance of \>=1 new lesions. For non-target disease: PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion was also considered PD. Analysis was performed using Kaplan-Meier method.
Outcome measures
| Measure |
50 mg Encorafenib QD
n=9 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=16 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
n=12 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PFS: Dose Expansion Phase
|
16.5 Months
Interval 7.4 to
Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
19.3 Months
Interval 7.4 to
Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
0.6 Months
Interval 0.6 to
Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
2.0 Months
Interval 1.6 to 3.7
|
20.1 Months
Interval 10.9 to
Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
4.5 Months
Interval 2.3 to 7.2
|
4.0 Months
Interval 1.8 to 5.5
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first observation of response until first time of PD or death due to any cause (Maximum of 556.1 weeks of treatment exposure)Population: FAS included all participants who received at least one dose of encorafenib. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Only participants with complete or partial response were included in the analysis.
DOR was defined as the time from first observation of response CR or partial response \[PR\]) to the first time of progression or death. CR was defined as complete disappearance of all target and non-target lesions, and sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. For target disease, PD=at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study, sum also demonstrated absolute increase of \>= 5 mm, or appearance of \>=1 new lesions. For non-target disease: PD=unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion.
Outcome measures
| Measure |
50 mg Encorafenib QD
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR): Dose Escalation Phase
|
NA Months
Median and 95% CI could not be calculated due to insufficient number of participants with events.
|
NA Months
Median and 95% CI could not be calculated due to insufficient number of participants with events.
|
NA Months
Median and 95% CI could not be calculated due to insufficient number of participants with events.
|
NA Months
Median and 95% CI could not be calculated due to insufficient number of participants with events.
|
NA Months
Median and 95% CI could not be calculated due to insufficient number of participants with events.
|
NA Months
Median and 95% CI could not be calculated due to insufficient number of participants with events.
|
—
|
NA Months
Median and 95% CI could not be calculated due to insufficient number of participants with events.
|
NA Months
Median and 95% CI could not be calculated due to insufficient number of participants with events.
|
NA Months
Median and 95% CI could not be calculated due to insufficient number of participants with events.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From date of start of treatment until CR or PR or censoring date (maximum of 556.1 weeks of treatment exposure)Population: FAS included all participants who received at least one dose of encorafenib.'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Only participants with complete or partial response were included in the analysis.
TTR was defined as the time from date of treatment until first documented response (CR or PR). CR was defined as complete disappearance of all target and non-target lesions sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) reduced in short axis to \<10 mm. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not achieve a confirmed PR or CR, were censored at last adequate tumor assessment date when they did not progress (including deaths not due to underlying disease) or at maximum follow-up (from study start to study end date) when participant had an event for progression-free survival. Individual participant data have been reported for this outcome measure.
Outcome measures
| Measure |
50 mg Encorafenib QD
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Response (TTR): Dose Escalation Phase
Participant 1
|
57 Days
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Response (TTR): Dose Escalation Phase
Participant 2
|
952 Days
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Response (TTR): Dose Escalation Phase
Participant 3
|
22 Days
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Response (TTR): Dose Escalation Phase
Participant 4
|
—
|
55 Days
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Response (TTR): Dose Escalation Phase
Participant 5
|
—
|
—
|
897 Days
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Response (TTR): Dose Escalation Phase
Participant 6
|
—
|
—
|
21 Days
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Response (TTR): Dose Escalation Phase
Participant 7
|
—
|
—
|
72 Days
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Response (TTR): Dose Escalation Phase
Participant 8
|
—
|
—
|
—
|
—
|
27 Days
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Response (TTR): Dose Escalation Phase
Participant 9
|
—
|
—
|
—
|
—
|
57 Days
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Response (TTR): Dose Escalation Phase
Participant 10
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
57 Days
|
—
|
—
|
—
|
—
|
|
Time to Response (TTR): Dose Escalation Phase
Participant 11
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
627 Days
|
—
|
—
|
—
|
—
|
|
Time to Response (TTR): Dose Escalation Phase
Participant 12
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
56 Days
|
—
|
—
|
—
|
|
Time to Response (TTR): Dose Escalation Phase
Participant 13
|
—
|
—
|
—
|
28 Days
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Response (TTR): Dose Escalation Phase
Participant 14
|
—
|
—
|
—
|
—
|
—
|
280 Days
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Response (TTR): Dose Escalation Phase
Participant 15
|
—
|
—
|
—
|
—
|
—
|
22 Days
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Response (TTR): Dose Escalation Phase
Participant 16
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
22 Days
|
—
|
—
|
—
|
—
|
—
|
|
Time to Response (TTR): Dose Escalation Phase
Participant 17
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
29 Days
|
—
|
—
|
—
|
—
|
—
|
|
Time to Response (TTR): Dose Escalation Phase
Participant 18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
727 Days
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first observation of response until first time of PD or death due to any cause (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)Population: FAS included all participants who received at least one dose of encorafenib.'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Only participants with complete or partial response were included in the analysis.
DOR was defined as the time from first observation of response (CR or PR\] to the first time of progression or death. CR was defined as complete disappearance of all target and non-target lesions and sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to (\<10 mm. PR defined as at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. For target disease, PD=at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study, sum also demonstrated absolute increase of \>= 5 mm, or appearance of \>=1 new lesions. For non-target disease: PD=unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion.
Outcome measures
| Measure |
50 mg Encorafenib QD
n=7 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
DOR: Dose Expansion Phase
|
NA Months
Median and 95% CI could not be calculated due to insufficient number of participants with events.
|
NA Months
Median and 95% CI could not be calculated due to insufficient number of participants with events.
|
—
|
NA Months
Median and 95% CI could not be calculated due to insufficient number of participants with events.
|
NA Months
Median and 95% CI could not be calculated due to insufficient number of participants with events.
|
NA Months
Median and 95% CI could not be calculated due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From date of start of treatment until CR or PR or censoring date (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)Population: FAS included all participants who received at least one dose of encorafenib. 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Only participants with complete or partial response were included in the analysis.
TTR was defined as the time from date of treatment until first documented response (CR or PR). CR was defined as complete disappearance of all target and non-target lesions sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) reduced in short axis to \<10 mm. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not achieve a confirmed PR or CR, were censored at last adequate tumor assessment date when they did not progress (including deaths not due to underlying disease) or at maximum follow-up (from study start to study end date) when participant had an event for progression-free survival. Individual participant data have been reported for this outcome measure.
Outcome measures
| Measure |
50 mg Encorafenib QD
n=7 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
TTR: Dose Expansion Phase
Participant 1
|
211 Days
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
TTR: Dose Expansion Phase
Participant 2
|
22 Days
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
TTR: Dose Expansion Phase
Participant 3
|
23 Days
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
TTR: Dose Expansion Phase
Participant 4
|
22 Days
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
TTR: Dose Expansion Phase
Participant 5
|
56 Days
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
TTR: Dose Expansion Phase
Participant 6
|
23 Days
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
TTR: Dose Expansion Phase
Participant 7
|
56 Days
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
TTR: Dose Expansion Phase
Participant 8
|
—
|
78 Days
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
TTR: Dose Expansion Phase
Participant 9
|
—
|
111 Days
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
TTR: Dose Expansion Phase
Participant 10
|
—
|
—
|
—
|
391 Days
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
TTR: Dose Expansion Phase
Participant 11
|
—
|
—
|
—
|
22 Days
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
TTR: Dose Expansion Phase
Participant 12
|
—
|
—
|
—
|
32 Days
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
TTR: Dose Expansion Phase
Participant 13
|
—
|
—
|
—
|
28 Days
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
TTR: Dose Expansion Phase
Participant 14
|
—
|
—
|
—
|
—
|
25 Days
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
TTR: Dose Expansion Phase
Participant 15
|
—
|
—
|
—
|
—
|
—
|
53 Days
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment until date of death or censoring date (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)Population: FAS included all participants who received at least one dose of encorafenib.
Overall survival was defined as the time from the date of first study treatment to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.
Outcome measures
| Measure |
50 mg Encorafenib QD
n=9 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=16 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
n=12 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS): Dose Expansion Phase
|
NA Months
Interval 11.6 to
Median and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
12.5 Months
Interval 7.7 to
Upper limit of 95% CI could not be calculated due to insufficient number of participants with events
|
NA Months
Interval 2.4 to
Median and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
9.5 Months
Interval 3.7 to 13.2
|
NA Months
Interval 30.7 to
Median and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
7.2 Months
Interval 5.6 to 10.5
|
8.0 Months
Interval 4.0 to
Upper limit of 95% CI could not be calculated due to insufficient number of participants with events
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)Population: Pharmacokinetic Analysis Set (PAS) consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Outcome measures
| Measure |
50 mg Encorafenib QD
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration of LGX818: Dose Escalation Phase
Cycle 1 Day 1
|
970 Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only 1 participant was analyzed
|
846 Nanogram per milliliter
Geometric Coefficient of Variation 82.92
|
1630 Nanogram per milliliter
Geometric Coefficient of Variation 42.36
|
1020 Nanogram per milliliter
Geometric Coefficient of Variation 49.06
|
1570 Nanogram per milliliter
Geometric Coefficient of Variation 28.82
|
733 Nanogram per milliliter
Geometric Coefficient of Variation 46.32
|
1850 Nanogram per milliliter
Geometric Coefficient of Variation 28.06
|
1200 Nanogram per milliliter
Geometric Coefficient of Variation 28.06
|
3310 Nanogram per milliliter
Geometric Coefficient of Variation 42.54
|
2510 Nanogram per milliliter
Geometric Coefficient of Variation 58.15
|
5970 Nanogram per milliliter
Geometric Coefficient of Variation 56.35
|
5360 Nanogram per milliliter
Geometric Coefficient of Variation 36.87
|
8980 Nanogram per milliliter
Geometric Coefficient of Variation 13.5
|
|
Maximum Observed Plasma Concentration of LGX818: Dose Escalation Phase
Cycle 1 Day 15
|
465 Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only 1 participant was analyzed
|
334 Nanogram per milliliter
Geometric Coefficient of Variation 57.7
|
959 Nanogram per milliliter
Geometric Coefficient of Variation 25.19
|
949 Nanogram per milliliter
Geometric Coefficient of Variation 27.4
|
1300 Nanogram per milliliter
Geometric Coefficient of Variation 29.08
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
1300 Nanogram per milliliter
Geometric Coefficient of Variation 1220
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
2920 Nanogram per milliliter
Geometric Coefficient of Variation 34.41
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
3950 Nanogram per milliliter
Geometric Coefficient of Variation 49.12
|
4170 Nanogram per milliliter
Geometric Coefficient of Variation 48.94
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)Population: PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Outcome measures
| Measure |
50 mg Encorafenib QD
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time Point of Maximum Concentration (Tmax) of LGX818: Dose Escalation Phase
Cycle 1 Day 15
|
2 Hours
Interval 2.0 to 2.0
|
0.5 Hours
Interval 0.5 to 2.0
|
2.99 Hours
Interval 2.0 to 4.0
|
0.5 Hours
Interval 0.5 to 0.533
|
2 Hours
Interval 0.5 to 2.03
|
NA Hours
Data could not be estimated as values were below limit of quantitation.
|
2 Hours
Interval 2.0 to 2.17
|
NA Hours
Data could not be estimated as values were below limit of quantitation.
|
2 Hours
Interval 2.0 to 2.02
|
NA Hours
Data could not be estimated as values were below limit of quantitation.
|
2 Hours
Interval 0.5 to 2.0
|
2 Hours
Interval 2.0 to 2.0
|
NA Hours
Data could not be estimated as values were below limit of quantitation.
|
|
Time Point of Maximum Concentration (Tmax) of LGX818: Dose Escalation Phase
Cycle 1 Day 1
|
2 Hours
Interval 2.0 to 2.0
|
0.5 Hours
Interval 0.167 to 0.5
|
2 Hours
Interval 0.5 to 2.0
|
2 Hours
Interval 0.5 to 2.0
|
2 Hours
Interval 0.517 to 3.95
|
2.02 Hours
Interval 2.0 to 4.08
|
2 Hours
Interval 2.0 to 2.0
|
2 Hours
Interval 2.0 to 2.08
|
2 Hours
Interval 2.0 to 8.0
|
1.25 Hours
Interval 0.5 to 2.25
|
2 Hours
Interval 2.0 to 2.33
|
2 Hours
Interval 2.0 to 2.07
|
2.04 Hours
Interval 2.0 to 2.08
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)Population: PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
AUC (inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.
Outcome measures
| Measure |
50 mg Encorafenib QD
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of LGX818: Dose Escalation Phase
Cycle 1 Day 1
|
5470 Hours*Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.
|
2340 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 70.37
|
7660 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 83.44
|
5050 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 39.57
|
9520 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 20.11
|
2220 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 53.66
|
9910 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 26.24
|
4410 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 69.51
|
20000 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 33.36
|
8940 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 50
|
33100 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 70.34
|
31900 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 45.51
|
64400 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 1.75
|
|
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of LGX818: Dose Escalation Phase
Cycle 1 Day 15
|
2700 Hours*Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.
|
1130 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 20.1
|
5380 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 36.87
|
2900 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 37.88
|
4830 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 11.11
|
NA Hours*Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
5080 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 35.87
|
NA Hours*Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
10200 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 53.84
|
NA Hours*Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
13200 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 34.77
|
15600 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 36.58
|
NA Hours*Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)Population: PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Outcome measures
| Measure |
50 mg Encorafenib QD
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Time Zero to Tau (AUCtau) of LGX818: Dose Escalation Phase
Cycle 1 Day 1
|
5360 Hours*Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.
|
2330 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 69.89
|
7610 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 82.98
|
5010 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 39.39
|
9400 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 20.06
|
3210 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 92.21
|
9860 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 26.5
|
4780 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 52.49
|
20300 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 29.06
|
8690 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 49.73
|
32800 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 69.05
|
31700 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 45.33
|
63900 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 1.41
|
|
Area Under the Concentration-Time Curve From Time Zero to Tau (AUCtau) of LGX818: Dose Escalation Phase
Cycle 1 Day 15
|
2660 Hours*Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.
|
1120 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 19.67
|
5330 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 36.58
|
2890 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 37.55
|
4750 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 12.25
|
NA Hours*Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
5060 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 35.79
|
NA Hours*Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
10100 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 53.35
|
NA Hours*Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
13100 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 34.85
|
15300 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 36.38
|
NA Hours*Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)Population: PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
t1/2 was the time measured for the plasma concentration to decrease by one half. Terminal phase half-life expressed in hours (hr).
Outcome measures
| Measure |
50 mg Encorafenib QD
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Elimination Half-life (t1/2) of LGX818: Dose Escalation Phase
Cycle 1 Day 15
|
4.14 Hours
Interval 4.14 to 4.14
|
3.71 Hours
Interval 3.66 to 5.63
|
3.99 Hours
Interval 3.22 to 4.05
|
3.61 Hours
Interval 3.26 to 4.1
|
3.65 Hours
Interval 3.43 to 7.47
|
NA Hours
Data could not be estimated as values were below limit of quantitation.
|
3.13 Hours
Interval 2.95 to 3.22
|
NA Hours
Data could not be estimated as values were below limit of quantitation.
|
3.57 Hours
Interval 1.61 to 4.06
|
NA Hours
Data could not be estimated as values were below limit of quantitation.
|
3.19 Hours
Interval 2.82 to 3.56
|
3.25 Hours
Interval 2.96 to 8.0
|
NA Hours
Data could not be estimated as values were below limit of quantitation.
|
|
Elimination Half-life (t1/2) of LGX818: Dose Escalation Phase
Cycle 1 Day 1
|
4.38 Hours
Interval 4.38 to 4.38
|
3.77 Hours
Interval 3.57 to 4.44
|
3.47 Hours
Interval 3.38 to 3.88
|
3.7 Hours
Interval 3.32 to 3.96
|
3.66 Hours
Interval 3.09 to 4.5
|
2.82 Hours
Interval 2.02 to 3.84
|
3.3 Hours
Interval 2.56 to 3.58
|
2.53 Hours
Interval 1.69 to 2.68
|
3.42 Hours
Interval 2.84 to 4.77
|
2.16 Hours
Interval 2.16 to 2.42
|
2.92 Hours
Interval 2.32 to 4.98
|
3.32 Hours
Interval 3.28 to 3.61
|
3.25 Hours
Interval 2.96 to 3.53
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)Population: PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Outcome measures
| Measure |
50 mg Encorafenib QD
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Total Plasma Clearance of Drug (CL/F) of LGX818: Dose Escalation Phase
Cycle 1 Day 1
|
9.14 Liter/hour
Geometric Coefficient of Variation NA
The geometric coefficient of variation could not be estimated as only 1 participant was analyzed.
|
21.3 Liter/hour
Geometric Coefficient of Variation 70.37
|
13 Liter/hour
Geometric Coefficient of Variation 83.44
|
19.8 Liter/hour
Geometric Coefficient of Variation 39.57
|
15.8 Liter/hour
Geometric Coefficient of Variation 20.11
|
33.8 Liter/hour
Geometric Coefficient of Variation 53.66
|
20.2 Liter/hour
Geometric Coefficient of Variation 26.24
|
22.7 Liter/hour
Geometric Coefficient of Variation 69.51
|
15 Liter/hour
Geometric Coefficient of Variation 33.36
|
16.8 Liter/hour
Geometric Coefficient of Variation 50
|
13.6 Liter/hour
Geometric Coefficient of Variation 70.34
|
17.2 Liter/hour
Geometric Coefficient of Variation 45.51
|
10.9 Liter/hour
Geometric Coefficient of Variation 1.75
|
|
Apparent Total Plasma Clearance of Drug (CL/F) of LGX818: Dose Escalation Phase
Cycle 1 Day 15
|
18.8 Liter/hour
Geometric Coefficient of Variation NA
The geometric coefficient of variation could not be estimated as only 1 participant was analyzed.
|
44.7 Liter/hour
Geometric Coefficient of Variation 19.67
|
18.8 Liter/hour
Geometric Coefficient of Variation 36.58
|
34.6 Liter/hour
Geometric Coefficient of Variation 37.55
|
31.5 Liter/hour
Geometric Coefficient of Variation 12.25
|
NA Liter/hour
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
39.5 Liter/hour
Geometric Coefficient of Variation 35.79
|
NA Liter/hour
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
29.6 Liter/hour
Geometric Coefficient of Variation 53.35
|
NA Liter/hour
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
34.3 Liter/hour
Geometric Coefficient of Variation 34.85
|
36 Liter/hour
Geometric Coefficient of Variation 36.38
|
NA Liter/hour
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)Population: PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Outcome measures
| Measure |
50 mg Encorafenib QD
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of LGX818: Dose Escalation Phase
Cycle 1 Day 15
|
112 Liter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.
|
274 Liter
Geometric Coefficient of Variation 7.68
|
103 Liter
Geometric Coefficient of Variation 36.42
|
182 Liter
Geometric Coefficient of Variation 33.22
|
188 Liter
Geometric Coefficient of Variation 43.23
|
NA Liter
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
177 Liter
Geometric Coefficient of Variation 31
|
NA Liter
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
128 Liter
Geometric Coefficient of Variation 12.49
|
NA Liter
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
157 Liter
Geometric Coefficient of Variation 38.55
|
221 Liter
Geometric Coefficient of Variation 75.92
|
NA Liter
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
|
Apparent Volume of Distribution (Vz/F) of LGX818: Dose Escalation Phase
Cycle 1 Day 1
|
57.8 Liter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.
|
120 Liter
Geometric Coefficient of Variation 56.42
|
67 Liter
Geometric Coefficient of Variation 79.38
|
104 Liter
Geometric Coefficient of Variation 35.34
|
84.5 Liter
Geometric Coefficient of Variation 28.15
|
116 Liter
Geometric Coefficient of Variation 27.23
|
91.9 Liter
Geometric Coefficient of Variation 39.62
|
73.8 Liter
Geometric Coefficient of Variation 39.95
|
76.5 Liter
Geometric Coefficient of Variation 33.65
|
53.9 Liter
Geometric Coefficient of Variation 49.07
|
60.5 Liter
Geometric Coefficient of Variation 53.31
|
84.8 Liter
Geometric Coefficient of Variation 41.99
|
50.7 Liter
Geometric Coefficient of Variation 10.87
|
SECONDARY outcome
Timeframe: From start of study treatment until first documentation of PD or death due to any cause or censoring date (maximum of 556.1 weeks of treatment exposure)Population: FAS included all participants who received at least one dose of encorafenib.
Tumor response included: CR, PR, stable disease and disease progression (PD). CR=complete disappearance of all target and non-target lesions sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) reduced in short axis to \<10 mm. PR=at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease=neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. For target disease, PD=at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study, sum also demonstrated absolute increase of \>= 5 mm, or appearance of \>=1 new lesions. For non-target disease: PD=unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion.
Outcome measures
| Measure |
50 mg Encorafenib QD
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
n=10 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
n=4 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
n=5 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants According to Tumor Response Per RECIST Criteria- Dose Escalation
Partial Response (PR)
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants According to Tumor Response Per RECIST Criteria- Dose Escalation
Stable Disease (SD)
|
0 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants According to Tumor Response Per RECIST Criteria- Dose Escalation
Progressive Disease (PD)
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants According to Tumor Response Per RECIST Criteria- Dose Escalation
Complete Response (CR)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)Population: PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Outcome measures
| Measure |
50 mg Encorafenib QD
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=10 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
n=10 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration of LGX818: Dose Expansion Phase
Cycle 1 Day 1
|
4310 Nanogram per milliliter
Geometric Coefficient of Variation 31.6
|
5650 Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.
|
7790 Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.
|
6580 Nanogram per milliliter
Geometric Coefficient of Variation 34.24
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
1340 Nanogram per milliliter
|
8380 Nanogram per milliliter
Geometric Coefficient of Variation 32.93
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration of LGX818: Dose Expansion Phase
Cycle 1 Day 8
|
1060 Nanogram per milliliter
Geometric Coefficient of Variation 41.1
|
—
|
—
|
5590 Nanogram per milliliter
Geometric Coefficient of Variation 22.56
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
—
|
5650 Nanogram per milliliter
Geometric Coefficient of Variation 79.98
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration of LGX818: Dose Expansion Phase
Cycle 1 Day 15
|
2050 Nanogram per milliliter
Geometric Coefficient of Variation 43.71
|
—
|
—
|
4960 Nanogram per milliliter
Geometric Coefficient of Variation 32.64
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
1040 Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.
|
5130 Nanogram per milliliter
Geometric Coefficient of Variation 48.81
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)Population: PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. 'Overall Number of Participants Analyzed' signifies number of participants with evaluable data for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Outcome measures
| Measure |
50 mg Encorafenib QD
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=10 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
n=10 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Vz/F of LGX818: Dose Expansion Phase
Cycle 1 Day 1
|
79.1 Liter
Geometric Coefficient of Variation 29.82
|
—
|
25.3 Liter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.
|
59.7 Liter
Geometric Coefficient of Variation 35.42
|
NA Liter
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
—
|
44.6 Liter
Geometric Coefficient of Variation 26.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Vz/F of LGX818: Dose Expansion Phase
Cycle 1 Day 8
|
219 Liter
Geometric Coefficient of Variation 41.9
|
—
|
—
|
66.1 Liter
Geometric Coefficient of Variation 23.07
|
NA Liter
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
—
|
70 Liter
Geometric Coefficient of Variation 40.28
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Vz/F of LGX818: Dose Expansion Phase
Cycle 1 Day 15
|
243 Liter
Geometric Coefficient of Variation 79
|
—
|
—
|
130 Liter
Geometric Coefficient of Variation 20.81
|
NA Liter
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
194 Liter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.
|
110 Liter
Geometric Coefficient of Variation 32.51
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)Population: PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Tmax was the time required to reach the maximum plasma concentration (Cmax). First observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in hours (hr).
Outcome measures
| Measure |
50 mg Encorafenib QD
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=10 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
n=10 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax of LGX818: Dose Expansion Phase
Cycle 1 Day 1
|
1.97 Hours
Interval 1.95 to 1.97
|
2.08 Hours
Interval 2.08 to 2.08
|
3.97 Hours
Interval 3.97 to 3.97
|
2 Hours
Interval 0.5 to 2.12
|
NA Hours
Data could not be estimated as values were below limit of quantitation.
|
—
|
2 Hours
Interval 0.667 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tmax of LGX818: Dose Expansion Phase
Cycle 1 Day 8
|
1.92 Hours
Interval 1.9 to 1.98
|
—
|
—
|
1.93 Hours
Interval 0.5 to 2.07
|
NA Hours
Data could not be estimated as values were below limit of quantitation.
|
—
|
2 Hours
Interval 0.5 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tmax of LGX818: Dose Expansion Phase
Cycle 1 Day 15
|
1.9 Hours
Interval 1.88 to 1.97
|
NA Hours
Data could not be estimated as values were below limit of quantitation.
|
NA Hours
Data could not be estimated as values were below limit of quantitation.
|
2 Hours
Interval 0.5 to 2.3
|
NA Hours
Data could not be estimated as values were below limit of quantitation.
|
4 Hours
Interval 4.0 to 4.0
|
2 Hours
Interval 1.97 to 2.08
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)Population: PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. 'Overall Number of Participants Analyzed' signifies number of participants with evaluable data for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
AUC (inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.
Outcome measures
| Measure |
50 mg Encorafenib QD
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=10 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
n=10 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUCinf of LGX818: Dose Expansion Phase
Cycle 1 Day 1
|
18200 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 32.37
|
—
|
70900 Hours*Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.
|
33300 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 39.98
|
NA Hours*Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
—
|
54400 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 42.97
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUCinf of LGX818: Dose Expansion Phase
Cycle 1 Day 8
|
4290 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 30.9
|
—
|
—
|
16600 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 23.69
|
NA Hours*Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
—
|
16400 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 34.68
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUCinf of LGX818: Dose Expansion Phase
Cycle 1 Day 15
|
2050 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 43.71
|
—
|
—
|
4960 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 32.64
|
NA Hours*Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
1040 Hours*Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.
|
17300 Hours*Nanogram per milliliter
Geometric Coefficient of Variation 38.06
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)Population: PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Outcome measures
| Measure |
50 mg Encorafenib QD
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=10 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
n=10 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUCtau of LGX818: Dose Expansion Phase
Cycle 1 Day 1
|
18100 hours*nanogram per milliliter
Geometric Coefficient of Variation 32.22
|
35300 hours*nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.
|
69300 hours*nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.
|
33200 hours*nanogram per milliliter
Geometric Coefficient of Variation 39.86
|
NA hours*nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
—
|
54400 hours*nanogram per milliliter
Geometric Coefficient of Variation 42.97
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUCtau of LGX818: Dose Expansion Phase
Cycle 1 Day 8
|
4290 hours*nanogram per milliliter
Geometric Coefficient of Variation 30.9
|
—
|
—
|
16600 hours*nanogram per milliliter
Geometric Coefficient of Variation 23.69
|
NA hours*nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
—
|
16400 hours*nanogram per milliliter
Geometric Coefficient of Variation 34.67
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUCtau of LGX818: Dose Expansion Phase
Cycle 1 Day 15
|
7380 hours*nanogram per milliliter
Geometric Coefficient of Variation 60.51
|
—
|
—
|
17600 hours*nanogram per milliliter
Geometric Coefficient of Variation 25.65
|
NA hours*nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
10400 hours*nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.
|
17300 hours*nanogram per milliliter
Geometric Coefficient of Variation 37.9
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)Population: PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Outcome measures
| Measure |
50 mg Encorafenib QD
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=10 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
n=10 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
t1/2 of LGX818: Dose Expansion Phase
Cycle 1 Day 1
|
3.36 Hours
Interval 3.0 to 3.65
|
4.04 Hours
Interval 4.04 to 4.04
|
4.14 Hours
Interval 4.14 to 4.14
|
3.07 Hours
Interval 2.61 to 3.38
|
NA Hours
Data could not be estimated as values were below limit of quantitation.
|
—
|
3.63 Hours
Interval 2.59 to 6.44
|
—
|
—
|
—
|
—
|
—
|
—
|
|
t1/2 of LGX818: Dose Expansion Phase
Cycle 1 Day 8
|
2.41 Hours
Interval 1.69 to 2.47
|
—
|
—
|
1.66 Hours
Interval 1.61 to 1.81
|
NA Hours
Data could not be estimated as values were below limit of quantitation.
|
—
|
1.76 Hours
Interval 1.62 to 1.98
|
—
|
—
|
—
|
—
|
—
|
—
|
|
t1/2 of LGX818: Dose Expansion Phase
Cycle 1 Day 15
|
4.33 Hours
Interval 3.47 to 4.75
|
—
|
—
|
3.37 Hours
Interval 2.87 to 4.24
|
NA Hours
Data could not be estimated as values were below limit of quantitation.
|
4.51 Hours
Interval 4.51 to 4.51
|
3.13 Hours
Interval 1.73 to 4.42
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)Population: PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. 'Overall Number of Participants Analyzed' signifies number of participants with evaluable data for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Outcome measures
| Measure |
50 mg Encorafenib QD
n=3 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=10 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=1 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
n=10 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
CL/F of LGX818: Dose Expansion Phase
Cycle 1 Day 15
|
40.7 liter/hour
Geometric Coefficient of Variation 60.51
|
—
|
—
|
25.6 liter/hour
Geometric Coefficient of Variation 25.65
|
NA liter/hour
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
29.9 liter/hour
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.
|
26 liter/hour
Geometric Coefficient of Variation 37.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
CL/F of LGX818: Dose Expansion Phase
Cycle 1 Day 1
|
16.5 liter/hour
Geometric Coefficient of Variation 32.37
|
—
|
4.23 liter/hour
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.
|
13.5 liter/hour
Geometric Coefficient of Variation 39.98
|
NA liter/hour
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
—
|
8.27 liter/hour
Geometric Coefficient of Variation 42.97
|
—
|
—
|
—
|
—
|
—
|
—
|
|
CL/F of LGX818: Dose Expansion Phase
Cycle 1 Day 8
|
70.1 liter/hour
Geometric Coefficient of Variation 30.98
|
—
|
—
|
27.2 liter/hour
Geometric Coefficient of Variation 23.63
|
NA liter/hour
Geometric Coefficient of Variation NA
Data could not be estimated as values were below limit of quantitation.
|
—
|
27.4 liter/hour
Geometric Coefficient of Variation 34.67
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: (Baseline) last non-missing value prior to the first dose (Baseline)Population: FAS included all participants who received at least one dose of Encorafenib
Number of participants according to BRAF V600 mutation status as V600E (i.e., mutation of the BRAF gene in which valine \[V\] was substituted by glutamic acid \[E\] at amino acid 600) or other is reported in this outcome measure.
Outcome measures
| Measure |
50 mg Encorafenib QD
n=9 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=16 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
n=12 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants According to BRAF V600 Mutation Status at Baseline: Dose Expansion
V600E
|
8 Participants
|
5 Participants
|
1 Participants
|
16 Participants
|
1 Participants
|
6 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to BRAF V600 Mutation Status at Baseline: Dose Expansion
Others
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment until first documentation of PD or death due to any cause or censoring date (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)Population: FAS included all participants who received at least one dose of encorafenib.
umor response included: CR, PR, stable disease and disease progression (PD). CR=complete disappearance of all target and non-target lesions sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) reduced in short axis to \<10 mm. PR=at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease=neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. For target disease, PD=at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study, sum also demonstrated absolute increase of \>= 5 mm, or appearance of \>=1 new lesions. For non-target disease: PD=unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion.
Outcome measures
| Measure |
50 mg Encorafenib QD
n=9 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib QD
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
75 mg Encorafenib BID
n=16 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
200 mg Encorafenib QD
n=2 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
100 mg Encorafenib BID
n=6 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
300 mg Encorafenib QD
n=12 Participants
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants According to Tumor Response Per RECIST Criteria: Dose Expansion
Complete Response (CR)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Tumor Response Per RECIST Criteria: Dose Expansion
Partial Response (PR)
|
6 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Tumor Response Per RECIST Criteria: Dose Expansion
Stable Disease (SD)
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Tumor Response Per RECIST Criteria: Dose Expansion
Progressive Disease (PD)
|
1 Participants
|
0 Participants
|
2 Participants
|
8 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Dose Escalation: 50 mg Encorafenib QD
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Dose Escalation: 100 mg Encorafenib QD
Serious events: 7 serious events
Other events: 10 other events
Deaths: 3 deaths
Dose Escalation:150 mg Encorafenib QD
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Dose Escalation: 75 mg Encorafenib BID
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Escalation: 200 mg Encorafenib QD
Serious events: 4 serious events
Other events: 4 other events
Deaths: 1 deaths
Dose Escalation: 100 mg Encorafenib BID
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
Dose Escalation: 300 mg Encorafenib QD
Serious events: 4 serious events
Other events: 5 other events
Deaths: 2 deaths
Dose Escalation: 150 mg Encorafenib BID
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Dose Escalation: 450 mg Encorafenib QD
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Dose Escalation: 550 mg Encorafenib QD
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Dose Escalation: 700 mg Encorafenib QD
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Dose Expansion: Mel Naive 300 mg Encorafenib
Serious events: 2 serious events
Other events: 8 other events
Deaths: 2 deaths
Dose Expansion: Mel Naive 450 mg Encorafenib
Serious events: 4 serious events
Other events: 5 other events
Deaths: 3 deaths
Dose Expansion: Mel Pre-treated 300 mg Encorafenib
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
Dose Expansion: Mel Pre-treated 450 mg Encorafenib
Serious events: 9 serious events
Other events: 15 other events
Deaths: 11 deaths
Dose Expansion: Mel Stepwise 450 mg Encorafenib
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
Dose Expansion: Metastatic Colorectal Cancer 300 mg Encorafenib
Serious events: 3 serious events
Other events: 6 other events
Deaths: 5 deaths
Dose Expansion: Metastatic Colorectal Cancer 450 mg Encorafenib
Serious events: 6 serious events
Other events: 12 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Dose Escalation: 50 mg Encorafenib QD
n=4 participants at risk
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 mg encorafenib (LGX818) orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity
|
Dose Escalation: 100 mg Encorafenib QD
n=10 participants at risk
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity
|
Dose Escalation:150 mg Encorafenib QD
n=6 participants at risk
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Dose Escalation: 75 mg Encorafenib BID
n=3 participants at risk
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Dose Escalation: 200 mg Encorafenib QD
n=4 participants at risk
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Dose Escalation: 100 mg Encorafenib BID
n=5 participants at risk
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Dose Escalation: 300 mg Encorafenib QD
n=5 participants at risk
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Dose Escalation: 150 mg Encorafenib BID
n=4 participants at risk
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Dose Escalation: 450 mg Encorafenib QD
n=6 participants at risk
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Dose Escalation: 550 mg Encorafenib QD
n=5 participants at risk
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Dose Escalation: 700 mg Encorafenib QD
n=2 participants at risk
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Dose Expansion: Mel Naive 300 mg Encorafenib
n=9 participants at risk
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Dose Expansion: Mel Naive 450 mg Encorafenib
n=6 participants at risk
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Dose Expansion: Mel Pre-treated 300 mg Encorafenib
n=2 participants at risk
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Dose Expansion: Mel Pre-treated 450 mg Encorafenib
n=16 participants at risk
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Dose Expansion: Mel Stepwise 450 mg Encorafenib
n=2 participants at risk
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
|
Dose Expansion: Metastatic Colorectal Cancer 300 mg Encorafenib
n=6 participants at risk
Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
|
Dose Expansion: Metastatic Colorectal Cancer 450 mg Encorafenib
n=12 participants at risk
Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Brain oedema
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
1/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Eye disorders
Visual impairment
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
1/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
1/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
1/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
2/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
General disorders
Asthenia
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
12.5%
2/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
General disorders
Fatigue
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
General disorders
General physical health deterioration
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
General disorders
Multi-organ failure
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Brain herniation
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
2/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dysplastic naevus
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
2/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Nervous system disorders
Partial seizures
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
2/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
1/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
General disorders
Face oedema
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Infections and infestations
Device related infection
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Infections and infestations
Localised infection
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Infections and infestations
Septic shock
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
12.5%
2/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of head and neck
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Nervous system disorders
Migraine
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
1/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
1/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
1/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
3/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
18.8%
3/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
Other adverse events
| Measure |
Dose Escalation: 50 mg Encorafenib QD
n=4 participants at risk
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 mg encorafenib (LGX818) orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity
|
Dose Escalation: 100 mg Encorafenib QD
n=10 participants at risk
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity
|
Dose Escalation:150 mg Encorafenib QD
n=6 participants at risk
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Dose Escalation: 75 mg Encorafenib BID
n=3 participants at risk
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Dose Escalation: 200 mg Encorafenib QD
n=4 participants at risk
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Dose Escalation: 100 mg Encorafenib BID
n=5 participants at risk
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Dose Escalation: 300 mg Encorafenib QD
n=5 participants at risk
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Dose Escalation: 150 mg Encorafenib BID
n=4 participants at risk
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Dose Escalation: 450 mg Encorafenib QD
n=6 participants at risk
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Dose Escalation: 550 mg Encorafenib QD
n=5 participants at risk
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Dose Escalation: 700 mg Encorafenib QD
n=2 participants at risk
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Dose Expansion: Mel Naive 300 mg Encorafenib
n=9 participants at risk
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Dose Expansion: Mel Naive 450 mg Encorafenib
n=6 participants at risk
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Dose Expansion: Mel Pre-treated 300 mg Encorafenib
n=2 participants at risk
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Dose Expansion: Mel Pre-treated 450 mg Encorafenib
n=16 participants at risk
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
|
Dose Expansion: Mel Stepwise 450 mg Encorafenib
n=2 participants at risk
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
|
Dose Expansion: Metastatic Colorectal Cancer 300 mg Encorafenib
n=6 participants at risk
Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
|
Dose Expansion: Metastatic Colorectal Cancer 450 mg Encorafenib
n=12 participants at risk
Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
30.0%
3/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
100.0%
2/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
2/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
12.5%
2/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Congenital, familial and genetic disorders
Ichthyosis
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Congenital, familial and genetic disorders
Keratosis follicular
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
12.5%
2/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Ear pain
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
1/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
2/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
2/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
66.7%
2/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
55.6%
5/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
4/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
3/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
3/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
30.0%
3/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
100.0%
3/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
60.0%
3/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
75.0%
3/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
3/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
44.4%
4/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
66.7%
4/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
100.0%
2/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
56.2%
9/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
2/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
30.0%
3/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
60.0%
3/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
100.0%
2/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
3/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
100.0%
2/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
43.8%
7/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
100.0%
2/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
83.3%
5/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
2/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
General disorders
Asthenia
|
75.0%
3/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
30.0%
3/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
56.2%
9/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
100.0%
2/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
41.7%
5/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
General disorders
Chills
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
22.2%
2/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
2/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
General disorders
Fatigue
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
2/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
66.7%
2/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
60.0%
3/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
3/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
12.5%
2/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
2/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
3/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
1/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
General disorders
Pyrexia
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
3/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
General disorders
Xerosis
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
5/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
31.2%
5/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
3/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Infections and infestations
Bronchitis
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Infections and infestations
Folliculitis
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
2/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
2/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
1/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
12.5%
2/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Investigations
Weight decreased
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
66.7%
4/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
1/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
3/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
3/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
12.5%
2/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
4/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
3/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
66.7%
2/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
60.0%
3/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
80.0%
4/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
44.4%
4/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
100.0%
2/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
18.8%
3/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
6/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
2/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
75.0%
3/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
4/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
3/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
66.7%
2/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
60.0%
3/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
60.0%
3/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
3/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
8/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
100.0%
2/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
41.7%
5/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
4/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
1/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
1/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
66.7%
2/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
60.0%
3/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
100.0%
2/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
55.6%
5/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
81.2%
13/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
58.3%
7/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
1/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
80.0%
4/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
60.0%
3/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
22.2%
2/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
12.5%
2/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
75.0%
3/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
30.0%
3/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
75.0%
3/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
3/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
4/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
3/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
2/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
12.5%
2/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
2/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
66.7%
2/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
1/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
18.8%
3/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
30.0%
3/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
44.4%
4/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
56.2%
9/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
1/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
2/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Nervous system disorders
Paraesthesia
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
1/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
3/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
62.5%
10/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
41.7%
5/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
1/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
2/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
1/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
60.0%
3/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
12.5%
2/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
1/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Acanthosis nigricans
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
2/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
75.0%
3/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
4/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
1/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
55.6%
5/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
8/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
4/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
30.0%
3/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
75.0%
3/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
12.5%
2/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
1/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
1/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
4/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
1/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
44.4%
4/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
8/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
58.3%
7/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
66.7%
2/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
30.0%
3/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
66.7%
4/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
3/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
12.5%
2/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
30.0%
3/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
18.8%
3/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
75.0%
3/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
70.0%
7/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
1/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
75.0%
3/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
60.0%
3/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
55.6%
5/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
31.2%
5/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
100.0%
2/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
3/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
3/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hypotrichosis
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Keratosis pilaris
|
75.0%
3/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
4/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
100.0%
3/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
60.0%
3/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
22.2%
2/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
56.2%
9/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
3/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
75.0%
3/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
60.0%
6/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
75.0%
3/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
80.0%
4/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
66.7%
4/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
44.4%
4/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
68.8%
11/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
100.0%
2/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
66.7%
4/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
66.7%
8/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Palmoplantar keratoderma
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
66.7%
2/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
12.5%
2/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
100.0%
2/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
2/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Papule
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
30.0%
3/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
1/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
2/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
70.0%
7/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
1/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
60.0%
3/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
22.2%
2/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
37.5%
6/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
100.0%
2/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
3/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
41.7%
5/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
2/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
40.0%
2/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
12.5%
2/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
4/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
2/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
2/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
1/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash follicular
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
1/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
10.0%
1/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
20.0%
1/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
3/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
2/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
2/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
25.0%
1/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
1/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
12.5%
2/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
1/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
General disorders
Chest pain
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
2/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
2/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
1/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Investigations
Lipase increased
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
2/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
1/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
12.5%
2/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
1/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
1/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papilloma
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
12.5%
2/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
22.2%
2/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
1/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
50.0%
1/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
1/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
33.3%
3/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
2/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
6.2%
1/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
16.7%
1/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
1/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Oral hyperkeratosis
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/10 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/3 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/4 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/5 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
11.1%
1/9 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
12.5%
2/16 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/2 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
0.00%
0/6 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
8.3%
1/12 • From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER