Trial Outcomes & Findings for A Phase 1b Study Of Axitinib In Combination With Crizotinib In Patients With Advanced Solid Tumors (NCT NCT01999972)
NCT ID: NCT01999972
Last Updated: 2020-09-24
Results Overview
Toxicity as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. DLT defined as any following events attributable to any (axitinib or crizotinib) or both agents in combination: hematologic (Grade 4 neutropenia, absolute neutrophil count\<1000/mm\^3 with single temperature of \>38.3 degrees celsius or sustained temperature of 38 degrees celsius for \>1 hour; \>=Grade 3 neutropenic infection; \>=Grade 3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia), non-hematologic (\>=Grade 3 toxicities \[except asymptomatic hypophosphatemia, hyperuricemia without signs, symptoms of gout, and tumor lysis syndrome\], nausea, vomiting or diarrhea persisted at Grade 3 or 4 despite maximal medical therapy; Grade 3 hypertension if persistent despite anti-hypertensives); In asymptomatic participant, Grade 3 QTc prolongation (QTc\>=501 msec) if persisted after correcting reversible causes, and failure to deliver \>=75 percent (%) of dose of each study drug.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
50 participants
Primary outcome timeframe
Cycle 1 (28 days)
Results posted on
2020-09-24
Participant Flow
This study was conducted in 2 parts: Part 1 (Dose escalation part to determine maximum tolerated dose \[MTD\] of axitinib in combination with crizotinib), Part 2 (Dose expansion part to assess the safety and tolerability of axitinib in combination with crizotinib at MTD determined in Part 1).
To understand the pharmacokinetic (PK) effects of crizotinib on axitinib, a 7-day lead-in period of single-agent axitinib directly preceding the administration of the crizotinib and axitinib combination was included prior to Cycle 1 in the dose escalation phase of the study.
Participant milestones
| Measure |
Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg
Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg
Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg
Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
|---|---|---|---|---|---|---|
|
Dose Escalation Part
STARTED
|
5
|
3
|
5
|
11
|
0
|
0
|
|
Dose Escalation Part
Treated
|
5
|
3
|
4
|
10
|
0
|
0
|
|
Dose Escalation Part
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation Part
NOT COMPLETED
|
5
|
3
|
5
|
11
|
0
|
0
|
|
Dose Expansion Part
STARTED
|
0
|
0
|
0
|
0
|
21
|
7
|
|
Dose Expansion Part
Treated
|
0
|
0
|
0
|
0
|
21
|
7
|
|
Dose Expansion Part
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion Part
NOT COMPLETED
|
0
|
0
|
0
|
0
|
21
|
7
|
Reasons for withdrawal
| Measure |
Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg
Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg
Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg
Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
|---|---|---|---|---|---|---|
|
Dose Escalation Part
Participant refused further follow-up
|
1
|
0
|
1
|
1
|
0
|
0
|
|
Dose Escalation Part
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Dose Escalation Part
Enrolled but not treated
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Dose Escalation Part
Disease progression
|
3
|
2
|
3
|
6
|
0
|
0
|
|
Dose Escalation Part
Adverse Event
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Dose Escalation Part
Global deterioration of health status
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Dose Expansion Part
Death
|
0
|
0
|
0
|
0
|
2
|
1
|
|
Dose Expansion Part
Disease progression
|
0
|
0
|
0
|
0
|
9
|
3
|
|
Dose Expansion Part
Sponsor decision
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Dose Expansion Part
Adverse Event
|
0
|
0
|
0
|
0
|
4
|
2
|
|
Dose Expansion Part
Participant's non-compliance
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Dose Expansion Part
Participant refused further follow-up
|
0
|
0
|
0
|
0
|
4
|
0
|
|
Dose Expansion Part
Changed to standard of care
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Phase 1b Study Of Axitinib In Combination With Crizotinib In Patients With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg
n=5 Participants
Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg
n=3 Participants
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg
n=4 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg
n=10 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg
n=21 Participants
Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg
n=7 Participants
Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
48.7 years
STANDARD_DEVIATION 14.5 • n=7 Participants
|
60.3 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
63.9 years
STANDARD_DEVIATION 6.0 • n=4 Participants
|
62.4 years
STANDARD_DEVIATION 7.9 • n=21 Participants
|
61.9 years
STANDARD_DEVIATION 8.9 • n=8 Participants
|
61.7 years
STANDARD_DEVIATION 8.1 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
34 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
46 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (28 days)Population: Per protocol analysis set:all enrolled participants who received at least 1 dose of study drug, experienced either DLT during first cycle,or completed first cycle observation period.Participants who lost to follow up before receiving at least 75% of planned first cycle dose due to reasons other than treatment-related AEs were not evaluable for DLT.
Toxicity as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. DLT defined as any following events attributable to any (axitinib or crizotinib) or both agents in combination: hematologic (Grade 4 neutropenia, absolute neutrophil count\<1000/mm\^3 with single temperature of \>38.3 degrees celsius or sustained temperature of 38 degrees celsius for \>1 hour; \>=Grade 3 neutropenic infection; \>=Grade 3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia), non-hematologic (\>=Grade 3 toxicities \[except asymptomatic hypophosphatemia, hyperuricemia without signs, symptoms of gout, and tumor lysis syndrome\], nausea, vomiting or diarrhea persisted at Grade 3 or 4 despite maximal medical therapy; Grade 3 hypertension if persistent despite anti-hypertensives); In asymptomatic participant, Grade 3 QTc prolongation (QTc\>=501 msec) if persisted after correcting reversible causes, and failure to deliver \>=75 percent (%) of dose of each study drug.
Outcome measures
| Measure |
Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg
n=3 Participants
Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg
n=3 Participants
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg
n=3 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg
n=8 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg
Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg
Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
|---|---|---|---|---|---|---|
|
Dose-Escalation Part: Number of Participants With Dose-Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: First dose of study drug until 28 days after last dose (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)Population: Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib.
An AE was any untoward medical occurrence in a participant who received study drugs (crizotinib and axitinib) without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and until 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Outcome measures
| Measure |
Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg
n=5 Participants
Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg
n=3 Participants
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg
n=4 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg
n=10 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg
n=21 Participants
Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg
n=7 Participants
Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
5 Participants
|
3 Participants
|
3 Participants
|
10 Participants
|
21 Participants
|
7 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
2 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
8 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: First dose of study drug until 28 days after last dose (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)Population: Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib.
Treatment-related AE was any untoward medical occurrence attributed to study drugs (crizotinib and axitinib) in a participant who received study drugs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and until 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Outcome measures
| Measure |
Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg
n=5 Participants
Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg
n=3 Participants
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg
n=4 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg
n=10 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg
n=21 Participants
Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg
n=7 Participants
Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
4 Participants
|
3 Participants
|
3 Participants
|
9 Participants
|
21 Participants
|
6 Participants
|
|
Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: First dose of study drug until 28 days after last dose (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)Population: Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib.
An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 (severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 = death. Treatment-emergent were events between first dose of study drug and until 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Outcome measures
| Measure |
Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg
n=5 Participants
Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg
n=3 Participants
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg
n=4 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg
n=10 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg
n=21 Participants
Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg
n=7 Participants
Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Grade 3 or Higher Adverse Events (AEs) as Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03
Grade 5 AEs
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events (AEs) as Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03
Grade 3 or 4 AEs
|
3 Participants
|
3 Participants
|
1 Participants
|
8 Participants
|
19 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)Population: Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Laboratory parameters included hematological and biochemistry parameters. Hematological parameters included haemoglobin (anemia, haemoglobin increased), lymphocytes (lymphopenia, lymphocyte count increased), neutrophils, platelets and white blood cells. Number of participants with hematological abnormalities by grades (as per NCI CTCAE version 4.03) were reported. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.
Outcome measures
| Measure |
Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg
n=3 Participants
Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg
n=3 Participants
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg
n=3 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg
n=10 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg
n=21 Participants
Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg
n=6 Participants
Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities
Lymphocyte count increased: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities
White blood cells: Grade 1
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities
Platelets: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities
Anemia: Grade 1
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
10 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities
Anemia: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities
Anemia: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities
Anemia: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities
Hemoglobin increased: Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities
Hemoglobin increased: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities
Hemoglobin increased: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities
Hemoglobin increased: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities
Lymphopenia: Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities
Lymphopenia: Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
7 Participants
|
4 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities
Lymphopenia: Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities
Lymphopenia: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities
Neutrophils (absolute): Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities
Neutrophils (absolute): Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities
Neutrophils (absolute): Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities
Neutrophils (absolute): : Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities
Platelets: Grade 1
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities
Platelets: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities
Platelets: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities
White blood cells: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities
White blood cells: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities
White blood cells: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities
Lymphocyte count increased: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities
Lymphocyte count increased: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities
Lymphocyte count increased: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)Population: Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows.
Laboratory parameters included hematological and biochemistry parameters. Biochemistry parameters/abnormalities included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin (total), creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia and gamma glutamyl transferase Number of participants with biochemistry test abnormalities by grades (NCI CTCAE version 4.03) were reported. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.
Outcome measures
| Measure |
Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg
n=3 Participants
Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg
n=3 Participants
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg
n=3 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg
n=10 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg
n=21 Participants
Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg
n=6 Participants
Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Alanine aminotransferase: Grade 1
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Alanine aminotransferase: Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Alanine aminotransferase: Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Alanine aminotransferase: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Alkaline phosphatase: Grade 1
|
1 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
9 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Alkaline phosphatase: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Alkaline phosphatase: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Alkaline phosphatase: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Aspartate aminotransferase: Grade 1
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Aspartate aminotransferase: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Aspartate aminotransferase: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Aspartate aminotransferase: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Bilirubin (total): Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Bilirubin (total): Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Bilirubin (total): Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Bilirubin (total): Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Creatinine: Grade 1
|
3 Participants
|
1 Participants
|
2 Participants
|
8 Participants
|
16 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Creatinine: Grade 2
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Creatinine: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Creatinine: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypercalcemia: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypercalcemia: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypercalcemia: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypercalcemia: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hyperglycemia: Grade 1
|
2 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
13 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hyperglycemia: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hyperglycemia: Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hyperglycemia: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hyperkalemia: Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hyperkalemia: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hyperkalemia: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hyperkalemia: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypermagnesemia: Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypermagnesemia: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypermagnesemia: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypermagnesemia: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypernatremia: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypernatremia: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypernatremia: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypernatremia: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypoalbuminemia: Grade 1
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypoalbuminemia: Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypoalbuminemia: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypoalbuminemia: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypocalcemia: Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
9 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypocalcemia: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypocalcemia: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypocalcemia: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypoglycemia: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypoglycemia: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypoglycemia: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypoglycemia: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypokalemia: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypokalemia: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypokalemia: Grade 3
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypokalemia: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypomagnesemia: Grade 1
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypomagnesemia: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypomagnesemia: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypomagnesemia: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hyponatremia: Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hyponatremia: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hyponatremia: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hyponatremia: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypophosphatemia: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypophosphatemia: Grade 2
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypophosphatemia: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Hypophosphatemia: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Gamma glutamyl transferase : Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Gamma glutamyl transferase : Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Gamma glutamyl transferase : Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities
Gamma glutamyl transferase : Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline; Day 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 6, 12, 24; and end of treatment (up to a maximum duration of 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)Population: Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. Here, '0' in the "number analyzed" field signifies that none of the participant were evaluable at specified time point.
Outcome measures
| Measure |
Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg
n=5 Participants
Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg
n=3 Participants
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg
n=4 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg
n=10 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg
n=21 Participants
Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg
n=7 Participants
Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment Visit
SBP: At Baseline
|
115.7 millimeters of mercury (mmHg)
Standard Deviation 13.66
|
116.2 millimeters of mercury (mmHg)
Standard Deviation 4.91
|
124.8 millimeters of mercury (mmHg)
Standard Deviation 9.17
|
113.6 millimeters of mercury (mmHg)
Standard Deviation 12.16
|
131.4 millimeters of mercury (mmHg)
Standard Deviation 15.58
|
139.7 millimeters of mercury (mmHg)
Standard Deviation 14.41
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment Visit
SBP: Change at Cycle 1 Day 1
|
2.0 millimeters of mercury (mmHg)
Standard Deviation 7.25
|
17.3 millimeters of mercury (mmHg)
Standard Deviation 2.25
|
14.5 millimeters of mercury (mmHg)
Standard Deviation 14.76
|
15.5 millimeters of mercury (mmHg)
Standard Deviation 14.92
|
-1.7 millimeters of mercury (mmHg)
Standard Deviation 19.34
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment Visit
SBP: Change at Cycle 1 Day 15
|
6.8 millimeters of mercury (mmHg)
Standard Deviation 9.00
|
3.5 millimeters of mercury (mmHg)
Standard Deviation 10.04
|
8.7 millimeters of mercury (mmHg)
Standard Deviation 9.45
|
12.0 millimeters of mercury (mmHg)
Standard Deviation 18.21
|
4.2 millimeters of mercury (mmHg)
Standard Deviation 17.06
|
-1.9 millimeters of mercury (mmHg)
Standard Deviation 9.47
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment Visit
SBP: Change at Cycle 2 Day 1
|
0.7 millimeters of mercury (mmHg)
Standard Deviation 8.13
|
4.3 millimeters of mercury (mmHg)
Standard Deviation 3.33
|
0.7 millimeters of mercury (mmHg)
Standard Deviation 9.81
|
0.9 millimeters of mercury (mmHg)
Standard Deviation 7.47
|
-1.8 millimeters of mercury (mmHg)
Standard Deviation 10.40
|
-11.5 millimeters of mercury (mmHg)
Standard Deviation 20.04
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment Visit
SBP: Change at Cycle 4 Day 1
|
—
|
3.5 millimeters of mercury (mmHg)
|
-5.8 millimeters of mercury (mmHg)
Standard Deviation 8.01
|
2.3 millimeters of mercury (mmHg)
Standard Deviation 17.01
|
-0.4 millimeters of mercury (mmHg)
Standard Deviation 12.75
|
-14.2 millimeters of mercury (mmHg)
Standard Deviation 7.54
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment Visit
SBP: Change at Cycle 6 Day 1
|
—
|
-15.0 millimeters of mercury (mmHg)
|
9.8 millimeters of mercury (mmHg)
Standard Deviation 19.45
|
1.5 millimeters of mercury (mmHg)
Standard Deviation 15.90
|
0.3 millimeters of mercury (mmHg)
Standard Deviation 18.57
|
-10.4 millimeters of mercury (mmHg)
Standard Deviation 17.50
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment Visit
SBP: Change at Cycle 12 Day 1
|
—
|
-7.5 millimeters of mercury (mmHg)
|
-7.0 millimeters of mercury (mmHg)
|
-7.3 millimeters of mercury (mmHg)
Standard Deviation 1.77
|
-5.8 millimeters of mercury (mmHg)
Standard Deviation 14.54
|
-14.0 millimeters of mercury (mmHg)
Standard Deviation 2.83
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment Visit
SBP: Change at Cycle 24 Day 1
|
—
|
—
|
7.0 millimeters of mercury (mmHg)
|
9.0 millimeters of mercury (mmHg)
|
-9.0 millimeters of mercury (mmHg)
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment Visit
SBP: End of Treatment
|
-7.0 millimeters of mercury (mmHg)
Standard Deviation 13.44
|
-4.8 millimeters of mercury (mmHg)
Standard Deviation 10.25
|
-14.0 millimeters of mercury (mmHg)
Standard Deviation 17.58
|
4.9 millimeters of mercury (mmHg)
Standard Deviation 9.32
|
-0.7 millimeters of mercury (mmHg)
Standard Deviation 15.17
|
-12.4 millimeters of mercury (mmHg)
Standard Deviation 22.00
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment Visit
DBP: At Baseline
|
76.8 millimeters of mercury (mmHg)
Standard Deviation 11.99
|
83.0 millimeters of mercury (mmHg)
Standard Deviation 4.77
|
83.5 millimeters of mercury (mmHg)
Standard Deviation 3.03
|
75.8 millimeters of mercury (mmHg)
Standard Deviation 7.66
|
78.5 millimeters of mercury (mmHg)
Standard Deviation 10.59
|
76.7 millimeters of mercury (mmHg)
Standard Deviation 10.37
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment Visit
DBP: Change at Cycle 1 Day 1
|
2.1 millimeters of mercury (mmHg)
Standard Deviation 4.57
|
4.2 millimeters of mercury (mmHg)
Standard Deviation 7.77
|
4.8 millimeters of mercury (mmHg)
Standard Deviation 5.30
|
7.0 millimeters of mercury (mmHg)
Standard Deviation 11.23
|
5.3 millimeters of mercury (mmHg)
Standard Deviation 8.84
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment Visit
DBP: Change at Cycle 1 Day 15
|
0.7 millimeters of mercury (mmHg)
Standard Deviation 12.34
|
-2.2 millimeters of mercury (mmHg)
Standard Deviation 1.04
|
2.5 millimeters of mercury (mmHg)
Standard Deviation 11.65
|
3.9 millimeters of mercury (mmHg)
Standard Deviation 8.51
|
1.8 millimeters of mercury (mmHg)
Standard Deviation 10.43
|
-7.5 millimeters of mercury (mmHg)
Standard Deviation 10.54
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment Visit
DBP: Change at Cycle 2 Day 1
|
-2.8 millimeters of mercury (mmHg)
Standard Deviation 7.09
|
-2.3 millimeters of mercury (mmHg)
Standard Deviation 2.57
|
0.5 millimeters of mercury (mmHg)
Standard Deviation 3.12
|
-2.3 millimeters of mercury (mmHg)
Standard Deviation 5.61
|
0.5 millimeters of mercury (mmHg)
Standard Deviation 8.36
|
-2.4 millimeters of mercury (mmHg)
Standard Deviation 6.01
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment Visit
DBP: Change at Cycle 4 Day 1
|
—
|
3.0 millimeters of mercury (mmHg)
|
-4.8 millimeters of mercury (mmHg)
Standard Deviation 2.02
|
-2.6 millimeters of mercury (mmHg)
Standard Deviation 7.94
|
-1.0 millimeters of mercury (mmHg)
Standard Deviation 10.24
|
-4.7 millimeters of mercury (mmHg)
Standard Deviation 4.89
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment Visit
DBP: Change at Cycle 6 Day 1
|
—
|
-17.5 millimeters of mercury (mmHg)
|
-0.5 millimeters of mercury (mmHg)
Standard Deviation 14.14
|
-6.0 millimeters of mercury (mmHg)
Standard Deviation 4.92
|
-3.0 millimeters of mercury (mmHg)
Standard Deviation 13.62
|
-1.4 millimeters of mercury (mmHg)
Standard Deviation 12.96
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment Visit
DBP: Change at Cycle 12 Day 1
|
—
|
-7.0 millimeters of mercury (mmHg)
|
2.5 millimeters of mercury (mmHg)
|
-7.5 millimeters of mercury (mmHg)
Standard Deviation 7.07
|
-0.3 millimeters of mercury (mmHg)
Standard Deviation 11.25
|
-5.5 millimeters of mercury (mmHg)
Standard Deviation 1.41
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment Visit
DBP: Change at Cycle 24 Day 1
|
—
|
—
|
-1.0 millimeters of mercury (mmHg)
|
7.0 millimeters of mercury (mmHg)
|
-6.5 millimeters of mercury (mmHg)
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment Visit
DBP: End of Treatment
|
-1.5 millimeters of mercury (mmHg)
Standard Deviation 4.44
|
-4.5 millimeters of mercury (mmHg)
Standard Deviation 4.24
|
-6.2 millimeters of mercury (mmHg)
Standard Deviation 8.13
|
-2.3 millimeters of mercury (mmHg)
Standard Deviation 9.58
|
-2.8 millimeters of mercury (mmHg)
Standard Deviation 10.94
|
-4.8 millimeters of mercury (mmHg)
Standard Deviation 11.17
|
SECONDARY outcome
Timeframe: Baseline; Day 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 6, 12, 24; and end of treatment (any time up to a maximum duration of 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)Population: Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. Here, '0' in the "number analyzed" field signifies that none of the participant were evaluable at specified time point.
Outcome measures
| Measure |
Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg
n=5 Participants
Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg
n=3 Participants
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg
n=4 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg
n=10 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg
n=21 Participants
Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg
n=7 Participants
Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Pulse Rate at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment
Pulse Rate: At Baseline
|
88.4 beats per minute (bpm)
Standard Deviation 21.76
|
81.2 beats per minute (bpm)
Standard Deviation 4.25
|
82.6 beats per minute (bpm)
Standard Deviation 15.05
|
80.9 beats per minute (bpm)
Standard Deviation 7.70
|
73.9 beats per minute (bpm)
Standard Deviation 14.71
|
77.4 beats per minute (bpm)
Standard Deviation 11.66
|
|
Change From Baseline in Pulse Rate at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment
Pulse Rate: Change at Cycle 1 Day 1
|
-0.6 beats per minute (bpm)
Standard Deviation 9.44
|
5.3 beats per minute (bpm)
Standard Deviation 9.29
|
-7.8 beats per minute (bpm)
Standard Deviation 1.44
|
-0.3 beats per minute (bpm)
Standard Deviation 9.15
|
-0.0 beats per minute (bpm)
Standard Deviation 12.25
|
—
|
|
Change From Baseline in Pulse Rate at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment
Pulse Rate: Change at Cycle 1 Day 15
|
-16.0 beats per minute (bpm)
Standard Deviation 7.26
|
-12.7 beats per minute (bpm)
Standard Deviation 6.33
|
-7.7 beats per minute (bpm)
Standard Deviation 26.63
|
-8.1 beats per minute (bpm)
Standard Deviation 9.20
|
-3.8 beats per minute (bpm)
Standard Deviation 11.55
|
-14.1 beats per minute (bpm)
Standard Deviation 11.93
|
|
Change From Baseline in Pulse Rate at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment
Pulse Rate: Change at Cycle 2 Day 1
|
-10.8 beats per minute (bpm)
Standard Deviation 15.25
|
-1.5 beats per minute (bpm)
Standard Deviation 6.14
|
-8.2 beats per minute (bpm)
Standard Deviation 23.91
|
-0.4 beats per minute (bpm)
Standard Deviation 12.09
|
-7.5 beats per minute (bpm)
Standard Deviation 11.39
|
-15.3 beats per minute (bpm)
Standard Deviation 13.26
|
|
Change From Baseline in Pulse Rate at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment
Pulse Rate: Change at Cycle 4 Day 1
|
—
|
-4.0 beats per minute (bpm)
|
-9.7 beats per minute (bpm)
Standard Deviation 4.54
|
-3.7 beats per minute (bpm)
Standard Deviation 8.45
|
-0.4 beats per minute (bpm)
Standard Deviation 16.15
|
-11.1 beats per minute (bpm)
Standard Deviation 7.97
|
|
Change From Baseline in Pulse Rate at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment
Pulse Rate: Change at Cycle 6 Day 1
|
—
|
-7.0 beats per minute (bpm)
|
-7.5 beats per minute (bpm)
Standard Deviation 7.78
|
-8.5 beats per minute (bpm)
Standard Deviation 13.31
|
-4.7 beats per minute (bpm)
Standard Deviation 18.60
|
-3.1 beats per minute (bpm)
Standard Deviation 23.69
|
|
Change From Baseline in Pulse Rate at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment
Pulse Rate: Change at Cycle 12 Day 1
|
—
|
1.0 beats per minute (bpm)
|
10.0 beats per minute (bpm)
|
-4.8 beats per minute (bpm)
Standard Deviation 6.72
|
-2.8 beats per minute (bpm)
Standard Deviation 9.75
|
-2.5 beats per minute (bpm)
Standard Deviation 7.78
|
|
Change From Baseline in Pulse Rate at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment
Pulse Rate: Change at Cycle 24 Day 1
|
—
|
—
|
-11.0 beats per minute (bpm)
|
-20.5 beats per minute (bpm)
|
2.0 beats per minute (bpm)
|
—
|
|
Change From Baseline in Pulse Rate at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment
Pulse Rate: Change at End of Treatment
|
-19.3 beats per minute (bpm)
Standard Deviation 11.59
|
8.0 beats per minute (bpm)
Standard Deviation 12.73
|
-2.8 beats per minute (bpm)
Standard Deviation 12.89
|
-1.2 beats per minute (bpm)
Standard Deviation 11.55
|
5.4 beats per minute (bpm)
Standard Deviation 20.42
|
17.6 beats per minute (bpm)
Standard Deviation 18.80
|
SECONDARY outcome
Timeframe: Baseline; Day 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 6, 12, 24; and end of treatment (any time up to a maximum duration of 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)Population: Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. Here, '0' in the "number analyzed" field signifies that none of the participant were evaluable at specified time point.
Outcome measures
| Measure |
Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg
n=5 Participants
Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg
n=3 Participants
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg
n=4 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg
n=10 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg
n=21 Participants
Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg
n=7 Participants
Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Body Weight at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment
Body Weight: Change at End of Treatment
|
-2.17 kilograms
Standard Deviation 5.327
|
-6.45 kilograms
Standard Deviation 6.576
|
-13.60 kilograms
Standard Deviation 7.400
|
-2.05 kilograms
Standard Deviation 7.134
|
-5.46 kilograms
Standard Deviation 5.505
|
-10.68 kilograms
Standard Deviation 9.058
|
|
Change From Baseline in Body Weight at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment
Body Weight: At Baseline
|
74.96 kilograms
Standard Deviation 11.339
|
87.43 kilograms
Standard Deviation 9.684
|
78.46 kilograms
Standard Deviation 13.938
|
82.63 kilograms
Standard Deviation 18.346
|
86.54 kilograms
Standard Deviation 17.044
|
93.00 kilograms
Standard Deviation 17.820
|
|
Change From Baseline in Body Weight at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment
Body Weight: Change at Cycle 1 Day 1
|
-1.03 kilograms
Standard Deviation 0.379
|
-1.43 kilograms
Standard Deviation 0.751
|
-1.51 kilograms
Standard Deviation 1.917
|
-0.98 kilograms
Standard Deviation 0.829
|
-0.63 kilograms
Standard Deviation 2.227
|
—
|
|
Change From Baseline in Body Weight at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment
Body Weight: Cycle 1 Day 15
|
-1.17 kilograms
Standard Deviation 1.747
|
-3.87 kilograms
Standard Deviation 2.003
|
-2.40 kilograms
Standard Deviation 3.064
|
-1.56 kilograms
Standard Deviation 1.565
|
-1.16 kilograms
Standard Deviation 2.305
|
-1.72 kilograms
Standard Deviation 1.648
|
|
Change From Baseline in Body Weight at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment
Body Weight: Change at Cycle 2 Day 1
|
-2.08 kilograms
Standard Deviation 3.123
|
-6.27 kilograms
Standard Deviation 2.403
|
-3.92 kilograms
Standard Deviation 3.806
|
-2.28 kilograms
Standard Deviation 2.689
|
-2.04 kilograms
Standard Deviation 3.109
|
-1.21 kilograms
Standard Deviation 3.734
|
|
Change From Baseline in Body Weight at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment
Body Weight: Change at Cycle 4 Day 1
|
—
|
-2.60 kilograms
|
-5.77 kilograms
Standard Deviation 5.228
|
-3.36 kilograms
Standard Deviation 2.783
|
-4.22 kilograms
Standard Deviation 4.118
|
-2.80 kilograms
Standard Deviation 3.609
|
|
Change From Baseline in Body Weight at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment
Body Weight: Change at Cycle 6 Day 1
|
—
|
-3.63 kilograms
|
-14.06 kilograms
|
-3.82 kilograms
Standard Deviation 5.538
|
-4.18 kilograms
Standard Deviation 5.232
|
-4.57 kilograms
Standard Deviation 6.264
|
|
Change From Baseline in Body Weight at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment
Body Weight: Change at Cycle 12 Day 1
|
—
|
-4.20 kilograms
|
-11.40 kilograms
|
2.11 kilograms
Standard Deviation 2.786
|
-3.53 kilograms
Standard Deviation 4.366
|
-6.15 kilograms
Standard Deviation 5.162
|
|
Change From Baseline in Body Weight at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment
Body Weight: Change at Cycle 24 Day 1
|
—
|
—
|
-16.50 kilograms
|
8.16 kilograms
|
-2.40 kilograms
|
—
|
SECONDARY outcome
Timeframe: Baseline, End of Treatment (up to Cycle 35 [for Part 1] and up to Cycle 35 [for Part 2], each cycle 28 days)Population: Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib.
ECOG-PS: used to assess how disease affected the daily living abilities of participant. It ranges on the scale from: 0-5 (0=fully active/able to carry on all pre-disease activities without restriction;1=restricted in physically strenuous activity but ambulatory/able to carry out light/sedentary work;2=ambulatory \[for more than (\>)50%of waking hours\], capable of all self-care but unable to carry out any work activities;3=capable of limited self-care, confined to bed or chair \[for \>50% of waking hours\];4=completely disabled, not capable of any self-care, totally confined to bed or chair;5= dead, higher score=more functional impairment) and changes to worst status scores were presented. Baseline value=value collected prior to first dose of study drug on Cycle 1 Day 1. Worst post-baseline value=worst value between first dose of any study drug and end of treatment (EOT) visit. Shift to low refers to lower than Baseline value; shift to high refers to higher than baseline value for ECOG-PS.
Outcome measures
| Measure |
Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg
n=5 Participants
Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg
n=3 Participants
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg
n=4 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg
n=10 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg
n=21 Participants
Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg
n=7 Participants
Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value
Baseline 0, EOT 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value
Baseline 0, EOT 1
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
8 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value
Baseline 0, EOT 2
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value
Baseline 0, EOT 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value
Baseline 0, EOT 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value
Baseline 1, EOT 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value
Baseline 1, EOT 1
|
3 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value
Baseline 1, EOT 2
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value
Baseline 1, EOT 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value
Baseline 1, EOT 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value
Baseline 2, EOT 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value
Baseline 2, EOT 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value
Baseline 2, EOT 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value
Baseline 2, EOT 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value
Baseline 2, EOT 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value
Baseline 3, EOT 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value
Baseline 3, EOT 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value
Baseline 3, EOT 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value
Baseline 3, EOT 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value
Baseline 3, EOT 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value
Baseline 4, EOT 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value
Baseline 4, EOT 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value
Baseline 4, EOT 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value
Baseline 4, EOT 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value
Baseline 4, EOT 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, End of Treatment (up to Cycle 35 [for Part 1] and up to Cycle 35 [for Part 2], each cycle 28 days)Population: Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib.
Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR) and by Bazette's formula (QTcB = QT divided by square root of RR). Number of participants with maximum increase from baseline of less than (\<) 30 milliseconds (msec), 30 to \<60 msec and greater than or equal to (\>=) 60 msec were reported.
Outcome measures
| Measure |
Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg
n=5 Participants
Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg
n=3 Participants
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg
n=4 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg
n=10 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg
n=21 Participants
Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg
n=7 Participants
Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Maximum Increase From Baseline in QTc Interval
QTcF (msec): <30
|
2 Participants
|
1 Participants
|
2 Participants
|
8 Participants
|
16 Participants
|
4 Participants
|
|
Number of Participants With Maximum Increase From Baseline in QTc Interval
QTcF (msec): 30-60
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Maximum Increase From Baseline in QTc Interval
QTcF (msec): >=60
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Increase From Baseline in QTc Interval
QTcB (msec): <30
|
3 Participants
|
1 Participants
|
1 Participants
|
8 Participants
|
15 Participants
|
4 Participants
|
|
Number of Participants With Maximum Increase From Baseline in QTc Interval
QTcB (msec): 30 - 60
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With Maximum Increase From Baseline in QTc Interval
QTcB (msec): >=60
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Axitinib: Pre-dose (0 hour [hr]), 1, 2, 3, 4, 6, 8 hrs post-dose at Lead-in Day 7, Cycle 1 Day 15; Crizotinib: pre-dose (0 hr), 1, 2, 3, 4, 6, 8 hrs post-dose at Cycle 1 Day 15Population: Pharmacokinetic (PK) parameter analysis population was defined as all treated participants who had at least 1 of the PK parameters of interest of any of the study drugs.
Data of this outcome measure was not planned to be analyzed for Cohort 2 in dose expansion part, as pre-specified in protocol.
Outcome measures
| Measure |
Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg
n=4 Participants
Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg
n=3 Participants
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg
n=3 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg
n=10 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg
n=12 Participants
Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg
Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Axitinib and Crizotinib
Axitinib: Lead-in Day 7
|
8.777 nanogram per milliliter
Geometric Coefficient of Variation 34
|
21.33 nanogram per milliliter
Geometric Coefficient of Variation 12
|
31.31 nanogram per milliliter
Geometric Coefficient of Variation 31
|
25.32 nanogram per milliliter
Geometric Coefficient of Variation 101
|
40.21 nanogram per milliliter
Geometric Coefficient of Variation 34
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Axitinib and Crizotinib
Axitinib: Cycle 1 Day 15
|
6.532 nanogram per milliliter
Geometric Coefficient of Variation 55
|
24.28 nanogram per milliliter
Geometric Coefficient of Variation 115
|
30.89 nanogram per milliliter
Geometric Coefficient of Variation 33
|
25.02 nanogram per milliliter
Geometric Coefficient of Variation 77
|
40.91 nanogram per milliliter
Geometric Coefficient of Variation 55
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Axitinib and Crizotinib
Crizotinib: Cycle 1 Day 15
|
194.8 nanogram per milliliter
Geometric Coefficient of Variation 6
|
230.8 nanogram per milliliter
Geometric Coefficient of Variation 35
|
169.9 nanogram per milliliter
Geometric Coefficient of Variation 298
|
207.0 nanogram per milliliter
Geometric Coefficient of Variation 43
|
235.9 nanogram per milliliter
Geometric Coefficient of Variation 99
|
—
|
SECONDARY outcome
Timeframe: Axitinib: Pre-dose (0 hour [hr]), 1, 2, 3, 4, 6, 8 hrs post-dose at Lead-in Day 7, Cycle 1 Day 15; Crizotinib: pre-dose (0 hr), 1, 2, 3, 4, 6, 8 hrs post-dose at Cycle 1 Day 15Population: The PK parameter analysis population was defined as all treated participants who had at least 1 of the PK parameters of interest of any of the study drugs.
Data of this outcome measure was not planned to be analyzed for Cohort 2 in dose expansion part, as pre-specified in protocol.
Outcome measures
| Measure |
Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg
n=4 Participants
Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg
n=3 Participants
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg
n=3 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg
n=10 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg
n=12 Participants
Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg
Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib and Crizotinib
Axitinib: Lead-in Day 7
|
2.09 hours
Interval 2.03 to 2.15
|
2.00 hours
Interval 1.03 to 2.0
|
2.48 hours
Interval 1.95 to 3.0
|
3.49 hours
Interval 1.0 to 4.0
|
2.00 hours
Interval 1.0 to 3.98
|
—
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib and Crizotinib
Axitinib: Cycle 1 Day 15
|
1.50 hours
Interval 1.0 to 2.0
|
3.00 hours
Interval 3.0 to 6.0
|
1.50 hours
Interval 1.0 to 2.0
|
1.50 hours
Interval 1.0 to 2.0
|
2.00 hours
Interval 1.0 to 3.0
|
—
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib and Crizotinib
Crizotinib: Cycle 1 Day 15
|
12.00 hours
Interval 12.0 to 12.0
|
3.92 hours
Interval 3.07 to 6.0
|
7.00 hours
Interval 2.0 to 12.0
|
3.00 hours
Interval 1.0 to 8.0
|
3.22 hours
Interval 1.0 to 8.08
|
—
|
SECONDARY outcome
Timeframe: Axitinib: Pre-dose (0 hour [hr]), 1, 2, 3, 4, 6, 8 hrs post-dose at Lead-in Day 7, Cycle 1 Day 15; Crizotinib: pre-dose (0 hr), 1, 2, 3, 4, 6, 8 hrs post-dose at Cycle 1 Day 15Population: The PK parameter analysis population was defined as all treated participants who had at least 1 of the PK parameters of interest of any of the study drugs.
Area under the plasma concentration versus time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 12 hours. Data of this outcome measure was not planned to be analyzed for Cohort 2 in dose expansion part, as pre-specified in protocol.
Outcome measures
| Measure |
Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg
n=4 Participants
Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg
n=3 Participants
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg
n=3 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg
n=10 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg
n=12 Participants
Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg
Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Axitinib and Crizotinib
Axitinib: Lead-in Day 7
|
31.96 nanogram*hour per milliliter
Geometric Coefficient of Variation 61
|
105.9 nanogram*hour per milliliter
Geometric Coefficient of Variation 29
|
131.6 nanogram*hour per milliliter
Geometric Coefficient of Variation 149
|
93.22 nanogram*hour per milliliter
Geometric Coefficient of Variation 135
|
197.8 nanogram*hour per milliliter
Geometric Coefficient of Variation 46
|
—
|
|
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Axitinib and Crizotinib
Axitinib: Cycle 1 Day 15
|
34.87 nanogram*hour per milliliter
Geometric Coefficient of Variation 65
|
143.8 nanogram*hour per milliliter
Geometric Coefficient of Variation 107
|
196.8 nanogram*hour per milliliter
Geometric Coefficient of Variation 6
|
127.4 nanogram*hour per milliliter
Geometric Coefficient of Variation 121
|
208.6 nanogram*hour per milliliter
Geometric Coefficient of Variation 35
|
—
|
|
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Axitinib and Crizotinib
Crizotinib: Cycle 1 Day 15
|
1905 nanogram*hour per milliliter
Geometric Coefficient of Variation 10
|
2162 nanogram*hour per milliliter
Geometric Coefficient of Variation 33
|
1526 nanogram*hour per milliliter
Geometric Coefficient of Variation 316
|
1985 nanogram*hour per milliliter
Geometric Coefficient of Variation 41
|
2144 nanogram*hour per milliliter
Geometric Coefficient of Variation 105
|
—
|
SECONDARY outcome
Timeframe: Axitinib: Pre-dose (0 hour [hr]), 1, 2, 3, 4, 6, 8 hrs post-dose at Lead-in Day 7, Cycle 1 Day 15; Crizotinib: pre-dose (0 hr), 1, 2, 3, 4, 6, 8 hrs post-dose at Cycle 1 Day 15Population: The PK parameter analysis population was defined as all treated participants who had at least 1 of the PK parameters of interest of any of the study drugs.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent oral clearance was obtained by dividing study drug dose with AUCtau, where AUCtau was area under the plasma concentration-time curve from time zero to the quantifiable concentration at the end of dosing interval. Data of this outcome measure was not planned to be analyzed for Cohort 2 in dose expansion part, as pre-specified in protocol.
Outcome measures
| Measure |
Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg
n=4 Participants
Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg
n=3 Participants
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg
n=3 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg
n=10 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg
n=12 Participants
Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg
Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
|---|---|---|---|---|---|---|
|
Apparent Oral Clearance (CL/F) of Axitinib and Crizotinib
Axitinib: Lead-in Day 7
|
94.06 liters per hour
Geometric Coefficient of Variation 61
|
28.32 liters per hour
Geometric Coefficient of Variation 29
|
38.03 liters per hour
Geometric Coefficient of Variation 149
|
53.70 liters per hour
Geometric Coefficient of Variation 134
|
25.32 liters per hour
Geometric Coefficient of Variation 46
|
—
|
|
Apparent Oral Clearance (CL/F) of Axitinib and Crizotinib
Axitinib: Cycle 1 Day 15
|
86.03 liters per hour
Geometric Coefficient of Variation 65
|
20.86 liters per hour
Geometric Coefficient of Variation 107
|
25.38 liters per hour
Geometric Coefficient of Variation 6
|
39.28 liters per hour
Geometric Coefficient of Variation 121
|
23.96 liters per hour
Geometric Coefficient of Variation 35
|
—
|
|
Apparent Oral Clearance (CL/F) of Axitinib and Crizotinib
Crizotinib: Cycle 1 Day 15
|
105.0 liters per hour
Geometric Coefficient of Variation 10
|
115.7 liters per hour
Geometric Coefficient of Variation 33
|
131.2 liters per hour
Geometric Coefficient of Variation 316
|
126.0 liters per hour
Geometric Coefficient of Variation 41
|
116.6 liters per hour
Geometric Coefficient of Variation 105
|
—
|
SECONDARY outcome
Timeframe: Axitinib: Pre-dose (0 hour [hr]), 1, 2, 3, 4, 6, 8 hrs post-dose at Lead-in Day 7, Cycle 1 Day 15; Crizotinib: pre-dose (0 hr), 1, 2, 3, 4, 6, 8 hrs post-dose at Cycle 1 Day 15Population: Data for this outcome measure was not collected due to change in planned analysis.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Baseline until disease progression or death, whichever occurred first (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)Population: Response-evaluable analysis set included all participants who received at least 1 dose of axitinib and crizotinib and had an adequate baseline tumor assessment.
Percentage of participants with objective response based on assessment of confirmed complete response \[CR\] or confirmed partial response \[PR\] according to Response Evaluation Criteria In Solid Tumors \[RECIST\] version1.1 were reported. Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.
Outcome measures
| Measure |
Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg
n=4 Participants
Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg
n=3 Participants
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg
n=3 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg
n=9 Participants
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg
n=20 Participants
Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg
n=7 Participants
Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Objective Response
|
0 percentage of participants
Interval 0.0 to 60.2
|
0 percentage of participants
Interval 0.0 to 70.8
|
0 percentage of participants
Interval 0.0 to 70.8
|
0 percentage of participants
Interval 0.0 to 33.6
|
40.0 percentage of participants
Interval 19.1 to 63.9
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
SECONDARY outcome
Timeframe: From first objective response until first recurrent, disease progression, or death, whichever occurred first (up to 35 cycles, each cycle 28 days)Population: Subset of response evaluable analysis set included all participants with overall objective response of CR or PR who received at least 1 dose of axitinib and crizotinib and had baseline tumor assessment. Data for this outcome measure was not planned to be collected and analyzed for "dose escalation part", as pre specified in protocol.
Duration of response (as per Response Evaluation Criteria in Solid Tumors \[RECIST\] version 1.1) was defined as the time (in months) from first documentation of objective tumor response (complete response \[CR\] or partial response \[PR\]) until the first date that recurrent, progressive disease, or death (whichever occurred first). CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. Progression was defined as \>= 20 percent increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions.
Outcome measures
| Measure |
Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg
n=8 Participants
Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg
n=1 Participants
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg
Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg
Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
|---|---|---|---|---|---|---|
|
Dose Expansion Part: Duration of Response
|
9.7 months
Interval 3.6 to 28.6
|
NA months
Data not estimable due to small number of participants with an event.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline until disease progression or death, whichever occurred first (up to 35 cycles, each cycle 28 days)Population: Response-evaluable analysis set included all participants who received at least 1 dose of axitinib and crizotinib and had an adequate baseline tumor assessment. Data for this outcome measure was not planned to be collected and analyzed for "dose escalation part", as pre specified in protocol.
PFS (as per Response Evaluation Criteria in Solid Tumors \[RECIST\] version 1.1) was defined as the time (in months) from start of study treatment to first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS (in months) was calculated as (first event date minus date of first dose of study medication plus 1) divided by 30.44. Progression was defined as \>= 20 percent increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions. PFS was not estimated in Dose Expansion Cohort 2 due to small sample size.
Outcome measures
| Measure |
Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg
n=20 Participants
Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg
n=7 Participants
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg
Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg
Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
|---|---|---|---|---|---|---|
|
Dose Expansion Part: Progression-Free Survival (PFS)
|
5.6 months
Interval 3.5 to 13.6
|
NA months
Data not estimable due to small number of participants with an event.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Cycle 2 Day 1, end of treatment (up to 35 cycles, each cycle 28 days)Population: Serum soluble protein biomarker analysis set included all enrolled participants who received at least one dose of any study drug, and had at least one biomarker parameter from the corresponding assay sample with at least one baseline biomarker measurement.
Serum soluble protein biomarkers included angiopoietin-2, Hepatocyte Growth Factor (HGF), Vascular Endothelial Growth Factor Receptor 3 (VEGFR 3). Biomarker analysis was not planned to be performed in dose escalation part and Cohort 2 of dose expansion part, as pre-specified in protocol.
Outcome measures
| Measure |
Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg
n=19 Participants
Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg
Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg
Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
|---|---|---|---|---|---|---|
|
Dose Expansion Part Cohort 1: Levels of Serum Soluble Protein Biomarkers
Angiopoietin-2: Baseline
|
4.84 nanograms per milliliter (ng/mL)
Standard Deviation 5.282
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part Cohort 1: Levels of Serum Soluble Protein Biomarkers
Angiopoietin-2: Cycle 2 Day 1
|
3.81 nanograms per milliliter (ng/mL)
Standard Deviation 2.351
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part Cohort 1: Levels of Serum Soluble Protein Biomarkers
Angiopoietin-2: End of Treatment
|
5.44 nanograms per milliliter (ng/mL)
Standard Deviation 2.996
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part Cohort 1: Levels of Serum Soluble Protein Biomarkers
HGF: Baseline
|
9.59 nanograms per milliliter (ng/mL)
Standard Deviation 4.831
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part Cohort 1: Levels of Serum Soluble Protein Biomarkers
HGF: Cycle 2 Day 1
|
15.58 nanograms per milliliter (ng/mL)
Standard Deviation 22.897
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part Cohort 1: Levels of Serum Soluble Protein Biomarkers
HGF: End of Treatment
|
11.95 nanograms per milliliter (ng/mL)
Standard Deviation 5.237
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part Cohort 1: Levels of Serum Soluble Protein Biomarkers
VEGFR3: Baseline
|
35.368 nanograms per milliliter (ng/mL)
Standard Deviation 8.6166
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part Cohort 1: Levels of Serum Soluble Protein Biomarkers
VEGFR3: Cycle 2 Day 1
|
26.000 nanograms per milliliter (ng/mL)
Standard Deviation 8.3314
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part Cohort 1: Levels of Serum Soluble Protein Biomarkers
VEGFR3: End of Treatment
|
36.444 nanograms per milliliter (ng/mL)
Standard Deviation 20.2426
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, end of treatment (up to 35 cycles, each cycle 28 days)Population: This outcome measure was not analyzed because of a change in planned analysis, due to the lack of strong evidence available supporting testing a hypothesis in the small sample set.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePopulation: Tumor Immunohistochemistry (IHC) analysis set included all enrolled participants who received at least one dose of any study drug, and had at least one biomarker parameter from the corresponding assay sample with at least one baseline biomarker measurement, and had confirmed objective response (CR+PR).
Percentage of c-MET positive tumor cell for objective response (complete response \[CR\] + partial response \[PR\]) is reported. Objective response was defined as CR and PR. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. Biomarker analysis was not planned to be performed in dose escalation part and Cohort 2 of dose expansion part, as pre-specified in protocol.
Outcome measures
| Measure |
Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg
n=5 Participants
Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg
Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg
Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
|---|---|---|---|---|---|---|
|
Dose Expansion Part Cohort 1: Percentage of c-MET Positive Tumor Cell at Baseline in Relation to Objective Response Rate (ORR)
Percent positive cell c-MET Cytoplasmic: CR +PR
|
70.0 percentage of positive tumor cells
Standard Deviation 25.50
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part Cohort 1: Percentage of c-MET Positive Tumor Cell at Baseline in Relation to Objective Response Rate (ORR)
Percent positive cell c-MET Membrane: CR + PR
|
85.0 percentage of positive tumor cells
Standard Deviation 20.62
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Day 1 and 15 of Cycle 1; Day 1 of Cycles 2, 3, 5; end of treatment (up to 35 cycles, each cycle 28 days)Population: Plasma soluble protein biomarker analysis set included all enrolled participants who received at least one dose of any study drug, and had at least one biomarker parameter from the corresponding assay sample with at least one baseline biomarker measurement.
Plasma soluble protein biomarker included c-MET. Biomarker analysis was not planned to be performed in dose escalation part and Cohort 2 of dose expansion part, as pre-specified in protocol.
Outcome measures
| Measure |
Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg
n=19 Participants
Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg
Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg
Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
|---|---|---|---|---|---|---|
|
Dose Expansion Part Cohort 1: Level of Plasma Soluble Protein Biomarker (c-MET)
c-MET: Baseline
|
640.0 nanogram per milliliter (ng/mL)
Standard Deviation 120.77
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part Cohort 1: Level of Plasma Soluble Protein Biomarker (c-MET)
c-MET: Cycle 1 Day 1
|
667.4 nanogram per milliliter (ng/mL)
Standard Deviation 117.09
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part Cohort 1: Level of Plasma Soluble Protein Biomarker (c-MET)
c-MET: Cycle 1 Day 15
|
694.8 nanogram per milliliter (ng/mL)
Standard Deviation 143.41
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part Cohort 1: Level of Plasma Soluble Protein Biomarker (c-MET)
c-MET: Cycle 2 Day 1
|
757.1 nanogram per milliliter (ng/mL)
Standard Deviation 148.75
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part Cohort 1: Level of Plasma Soluble Protein Biomarker (c-MET)
c-MET: Cycle 3 Day 1
|
678.2 nanogram per milliliter (ng/mL)
Standard Deviation 120.46
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part Cohort 1: Level of Plasma Soluble Protein Biomarker (c-MET)
c-MET: Cycle 5 Day 1
|
689.8 nanogram per milliliter (ng/mL)
Standard Deviation 158.09
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part Cohort 1: Level of Plasma Soluble Protein Biomarker (c-MET)
c-MET: End of Treatment
|
759.0 nanogram per milliliter (ng/mL)
Standard Deviation 183.74
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Cycle 2 Day 1, end of treatment (up to 35 cycles, each cycle 28 days)Population: Serum soluble protein biomarker analysis set: all enrolled participants who received at least 1 dose of any study drug, had at least 1 biomarker parameter from corresponding assay sample with at least 1 baseline biomarker measurement. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Serum soluble protein biomarkers included angiopoietin-2, Hepatocyte Growth Factor (HGF), Vascular Endothelial Growth Factor Receptor 3 (VEGFR3). Ratio=value of serum soluble protein biomarkers at each time point to the value at baseline. Biomarker analysis was not planned to be performed in dose escalation part and Cohort 2 of dose expansion part, as pre-specified in protocol.
Outcome measures
| Measure |
Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg
n=18 Participants
Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg
Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg
Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
|---|---|---|---|---|---|---|
|
Dose Expansion Part Cohort 1: Ratio of Serum Soluble Protein Biomarkers Level to Baseline Biomarkers Level by Each Timepoint
HGF (Cycle 2 Day 1 ratio Baseline)
|
1.62 ratio
Standard Deviation 1.449
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part Cohort 1: Ratio of Serum Soluble Protein Biomarkers Level to Baseline Biomarkers Level by Each Timepoint
Angiopoietin-2- (Cycle 2 Day 1 ratio Baseline)
|
0.90 ratio
Standard Deviation 0.321
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part Cohort 1: Ratio of Serum Soluble Protein Biomarkers Level to Baseline Biomarkers Level by Each Timepoint
Angiopoietin-2 (End of Treatment ratio Baseline)
|
1.50 ratio
Standard Deviation 1.056
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part Cohort 1: Ratio of Serum Soluble Protein Biomarkers Level to Baseline Biomarkers Level by Each Timepoint
HGF (End of Treatment ratio Baseline)
|
1.18 ratio
Standard Deviation 0.278
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part Cohort 1: Ratio of Serum Soluble Protein Biomarkers Level to Baseline Biomarkers Level by Each Timepoint
VEGFR3 (Cycle 2 Day 1 ratio Baseline)
|
0.748 ratio
Standard Deviation 0.1869
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part Cohort 1: Ratio of Serum Soluble Protein Biomarkers Level to Baseline Biomarkers Level by Each Timepoint
VEGFR3 (End of Treatment ratio Baseline)
|
0.969 ratio
Standard Deviation 0.6246
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg
Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths
Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg
Serious events: 8 serious events
Other events: 21 other events
Deaths: 2 deaths
Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg
Serious events: 3 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg
n=5 participants at risk
Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg
n=3 participants at risk
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg
n=4 participants at risk
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg
n=10 participants at risk
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg
n=21 participants at risk
Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg
n=7 participants at risk
Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
1/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.8%
1/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.8%
1/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.8%
1/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.8%
1/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Disease progression
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.5%
2/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Urinary tract infection
|
20.0%
1/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
28.6%
2/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Embolism
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
20.0%
2/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.8%
1/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.8%
1/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.8%
1/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.8%
1/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.5%
2/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.8%
1/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
Other adverse events
| Measure |
Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg
n=5 participants at risk
Participants received axitinib tablet at a dose of 3 milligrams (mg) orally, twice daily (BID) in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg
n=3 participants at risk
Participants received axitinib tablet at a dose of 3 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg
n=4 participants at risk
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 200 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg
n=10 participants at risk
Participants received axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg
n=21 participants at risk
Participants with advanced renal cell carcinoma (RCC) with no prior systemic therapy, received axitinib and crizotinib combination therapy at maximum tolerated dose (MTD) (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg
n=7 participants at risk
Participants with advanced RCC with at least one but no more than two prior systemic therapy, received axitinib and crizotinib combination therapy at MTD (axitinib tablet at a dose of 5 mg orally BID in combination with crizotinib capsule at a dose of 250 mg orally BID) in each 28-day cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor.
|
|---|---|---|---|---|---|---|
|
Endocrine disorders
Hypothyroidism
|
40.0%
2/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
66.7%
2/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
2/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
3/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
1/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
28.6%
2/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Sinus bradycardia
|
20.0%
1/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Eyelid pain
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.5%
2/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Vision blurred
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Photopsia
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
20.0%
2/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Visual impairment
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Vitreous floaters
|
20.0%
1/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
66.7%
2/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
3/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.8%
1/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
66.7%
2/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
2/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
20.0%
2/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
3/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
42.9%
3/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Diarrhoea
|
60.0%
3/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
75.0%
3/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
60.0%
6/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
76.2%
16/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
57.1%
4/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
2/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
30.0%
3/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
28.6%
6/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.5%
2/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
2/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
2/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
70.0%
7/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
90.5%
19/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
28.6%
2/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
20.0%
2/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
3/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Vomiting
|
80.0%
4/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
2/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
5/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
57.1%
12/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.5%
2/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Tongue discomfort
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Chills
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Asthenia
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Cyst
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Fatigue
|
20.0%
1/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
66.7%
2/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
75.0%
3/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
70.0%
7/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
42.9%
9/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
71.4%
5/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Influenza like illness
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Malaise
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
3/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Pain
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Oedema peripheral
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
3/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Ear infection
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
3/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
20.0%
2/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
7/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
1/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
23.8%
5/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood alkaline phosphatase increased
|
20.0%
1/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood urine present
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Electrocardiogram QT prolonged
|
20.0%
1/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
International normalised ratio increased
|
20.0%
1/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Liver function test increased
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Lymphocyte count decreased
|
40.0%
2/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
3/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Weight decreased
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
30.0%
3/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
38.1%
8/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
19.0%
4/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
42.9%
3/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
40.0%
2/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
100.0%
3/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
75.0%
3/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
5/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
7/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
28.6%
6/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
20.0%
1/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.8%
1/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.5%
2/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
40.0%
2/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
30.0%
3/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
3/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.0%
1/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
2/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
40.0%
2/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
19.0%
4/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.5%
2/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
23.8%
5/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
1/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
20.0%
2/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.5%
2/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
20.0%
1/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
20.0%
1/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.5%
2/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
20.0%
1/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.5%
2/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
20.0%
1/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
3/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.8%
1/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
28.6%
2/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
3/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Disturbance in attention
|
20.0%
1/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
19.0%
4/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
20.0%
2/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
3/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
3/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.0%
1/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Depression
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.5%
2/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Proteinuria
|
60.0%
3/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
66.7%
2/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
30.0%
3/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
23.8%
5/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Haematuria
|
20.0%
1/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
20.0%
2/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.8%
1/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
28.6%
2/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
66.7%
2/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
40.0%
4/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
52.4%
11/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
28.6%
2/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
20.0%
2/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.5%
2/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.5%
2/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
20.0%
1/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.8%
1/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
20.0%
2/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
20.0%
1/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.8%
1/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
28.6%
2/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
3/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
28.6%
2/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
20.0%
2/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.5%
2/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
20.0%
2/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
3/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.5%
2/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Embolism
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Hot flush
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Hypertension
|
40.0%
2/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
66.7%
2/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
2/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
40.0%
4/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
7/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
28.6%
2/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
3/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Orthostatic hypotension
|
20.0%
1/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.5%
2/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mass
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
1/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/5 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/10 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/21 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
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 publications 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