Trial Outcomes & Findings for KPT-9274 in Patients With Relapsed and Refractory Acute Myeloid Leukemia (NCT NCT04914845)
NCT ID: NCT04914845
Last Updated: 2026-01-27
Results Overview
Dose escalation will continue until the MTD is determined. The MTD is defined as the highest dose at which ≤1 patient experiences a DLT in Cycle 1. Count of participants who did not experience a DLT are listed in outcome measure data table.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
28 days
Results posted on
2026-01-27
Participant Flow
Participant milestones
| Measure |
De-escalation Cohort; 20mg
For the purposes of dose escalation decisions, a standard 3+3 dose escalation design will be used.The initial cohort, Cohort 1, will consist of 3 enrolled patients who will be treated at 30 mg. If the MTD is exceeded at cohort 1, de-escalation to cohort 0 (20 mg) will occur. If the MTD is not exceeded in cohort 1, dose escalation will continue based on a standard 3+3 design at the dose levels.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 1; 30 mg
The initial cohort, Cohort 1, will consist of 3 enrolled patients who will be treated at 30 mg.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 2; 40mg
Dose escalation to 40 mg after initial cohort (Cohort 1) after a minimum of 1 cycle of treatment, defined as receiving ≥75% of KPT-9274 doses during Cycle 1 (e.g., ≥9 of 12 doses in the 3 doses/week schedule), or have a DLT within the first cycle of treatment to be evaluable for dose escalation decisions.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 3; 60mg
Dose escalation to 60 mg after initial cohort (Cohort 1) after a minimum of 1 cycle of treatment, defined as receiving ≥75% of KPT-9274 doses during Cycle 1 (e.g., ≥9 of 12 doses in the 3 doses/week schedule), or have a DLT within the first cycle of treatment to be evaluable for dose escalation decisions.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 4; 80mg
Dose escalation to 80 mg after initial cohort (Cohort 1) after a minimum of 1 cycle of treatment, defined as receiving ≥75% of KPT-9274 doses during Cycle 1 (e.g., ≥9 of 12 doses in the 3 doses/week schedule), or have a DLT within the first cycle of treatment to be evaluable for dose escalation decisions.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 5; 100mg
Dose escalation to 100 mg after initial cohort (Cohort 1) after a minimum of 1 cycle of treatment, defined as receiving ≥75% of KPT-9274 doses during Cycle 1 (e.g., ≥9 of 12 doses in the 3 doses/week schedule), or have a DLT within the first cycle of treatment to be evaluable for dose escalation decisions.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
5
|
7
|
4
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
5
|
7
|
4
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
De-escalation Cohort; 20mg
For the purposes of dose escalation decisions, a standard 3+3 dose escalation design will be used.The initial cohort, Cohort 1, will consist of 3 enrolled patients who will be treated at 30 mg. If the MTD is exceeded at cohort 1, de-escalation to cohort 0 (20 mg) will occur. If the MTD is not exceeded in cohort 1, dose escalation will continue based on a standard 3+3 design at the dose levels.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 1; 30 mg
n=5 Participants
The initial cohort, Cohort 1, will consist of 3 enrolled patients who will be treated at 30 mg.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 2; 40mg
n=7 Participants
Dose escalation to 40 mg after initial cohort (Cohort 1) after a minimum of 1 cycle of treatment, defined as receiving ≥75% of KPT-9274 doses during Cycle 1 (e.g., ≥9 of 12 doses in the 3 doses/week schedule), or have a DLT within the first cycle of treatment to be evaluable for dose escalation decisions.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 3; 60mg
n=4 Participants
Dose escalation to 60 mg after initial cohort (Cohort 1) after a minimum of 1 cycle of treatment, defined as receiving ≥75% of KPT-9274 doses during Cycle 1 (e.g., ≥9 of 12 doses in the 3 doses/week schedule), or have a DLT within the first cycle of treatment to be evaluable for dose escalation decisions.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 4; 80mg
Dose escalation to 80 mg after initial cohort (Cohort 1) after a minimum of 1 cycle of treatment, defined as receiving ≥75% of KPT-9274 doses during Cycle 1 (e.g., ≥9 of 12 doses in the 3 doses/week schedule), or have a DLT within the first cycle of treatment to be evaluable for dose escalation decisions.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 5; 100mg
Dose escalation to 100 mg after initial cohort (Cohort 1) after a minimum of 1 cycle of treatment, defined as receiving ≥75% of KPT-9274 doses during Cycle 1 (e.g., ≥9 of 12 doses in the 3 doses/week schedule), or have a DLT within the first cycle of treatment to be evaluable for dose escalation decisions.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
Under 18 years of age
|
0 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
n=16 Participants
|
|
Age, Customized
18 years of age or older
|
0 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=4 Participants
|
0 Participants
|
0 Participants
|
16 Participants
n=16 Participants
|
|
Sex: Female, Male
Female
|
—
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=4 Participants
|
—
|
—
|
4 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
—
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=4 Participants
|
—
|
—
|
12 Participants
n=16 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 28 daysPopulation: No descalation cohort less than cohort 1 dose was needed. Due to DLTs, no patients enrolled to cohort 4 or 5.
Dose escalation will continue until the MTD is determined. The MTD is defined as the highest dose at which ≤1 patient experiences a DLT in Cycle 1. Count of participants who did not experience a DLT are listed in outcome measure data table.
Outcome measures
| Measure |
De-escalation Cohort; 20mg
For the purposes of dose escalation decisions, a standard 3+3 dose escalation design will be used.The initial cohort, Cohort 1, will consist of 3 enrolled patients who will be treated at 30 mg. If the MTD is exceeded at cohort 1, de-escalation to cohort 0 (20 mg) will occur. If the MTD is not exceeded in cohort 1, dose escalation will continue based on a standard 3+3 design at the dose levels.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 1; 30 mg
n=5 Participants
The initial cohort, Cohort 1, will consist of 3 enrolled patients who will be treated at 30 mg.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 2; 40mg
n=7 Participants
Dose escalation to 40 mg after initial cohort (Cohort 1) after a minimum of 1 cycle of treatment, defined as receiving ≥75% of KPT-9274 doses during Cycle 1 (e.g., ≥9 of 12 doses in the 3 doses/week schedule), or have a DLT within the first cycle of treatment to be evaluable for dose escalation decisions.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 3; 60mg
n=4 Participants
Dose escalation to 60 mg after initial cohort (Cohort 1) after a minimum of 1 cycle of treatment, defined as receiving ≥75% of KPT-9274 doses during Cycle 1 (e.g., ≥9 of 12 doses in the 3 doses/week schedule), or have a DLT within the first cycle of treatment to be evaluable for dose escalation decisions.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 4; 80mg
Dose escalation to 80 mg after initial cohort (Cohort 1) after a minimum of 1 cycle of treatment, defined as receiving ≥75% of KPT-9274 doses during Cycle 1 (e.g., ≥9 of 12 doses in the 3 doses/week schedule), or have a DLT within the first cycle of treatment to be evaluable for dose escalation decisions.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 5; 100mg
Dose escalation to 100 mg after initial cohort (Cohort 1) after a minimum of 1 cycle of treatment, defined as receiving ≥75% of KPT-9274 doses during Cycle 1 (e.g., ≥9 of 12 doses in the 3 doses/week schedule), or have a DLT within the first cycle of treatment to be evaluable for dose escalation decisions.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
—
|
5 participants
|
5 participants
|
2 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 daysPopulation: No descalation cohort less than cohort 1 dose was needed. Due to DLTs, no patients enrolled to cohort 4 or 5.
A RP2D equal to or less than the MTD will be declared after the MTD is determined and will be used for the Dose Expansion Phase, if conducted. After the RP2D is determined, a dose expansion phase, of up to 10 additional patients, might be conducted, in which a preliminary determination of efficacy will be conducted, using the ELN criteria.
Outcome measures
| Measure |
De-escalation Cohort; 20mg
For the purposes of dose escalation decisions, a standard 3+3 dose escalation design will be used.The initial cohort, Cohort 1, will consist of 3 enrolled patients who will be treated at 30 mg. If the MTD is exceeded at cohort 1, de-escalation to cohort 0 (20 mg) will occur. If the MTD is not exceeded in cohort 1, dose escalation will continue based on a standard 3+3 design at the dose levels.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 1; 30 mg
n=5 Participants
The initial cohort, Cohort 1, will consist of 3 enrolled patients who will be treated at 30 mg.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 2; 40mg
n=7 Participants
Dose escalation to 40 mg after initial cohort (Cohort 1) after a minimum of 1 cycle of treatment, defined as receiving ≥75% of KPT-9274 doses during Cycle 1 (e.g., ≥9 of 12 doses in the 3 doses/week schedule), or have a DLT within the first cycle of treatment to be evaluable for dose escalation decisions.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 3; 60mg
n=4 Participants
Dose escalation to 60 mg after initial cohort (Cohort 1) after a minimum of 1 cycle of treatment, defined as receiving ≥75% of KPT-9274 doses during Cycle 1 (e.g., ≥9 of 12 doses in the 3 doses/week schedule), or have a DLT within the first cycle of treatment to be evaluable for dose escalation decisions.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 4; 80mg
Dose escalation to 80 mg after initial cohort (Cohort 1) after a minimum of 1 cycle of treatment, defined as receiving ≥75% of KPT-9274 doses during Cycle 1 (e.g., ≥9 of 12 doses in the 3 doses/week schedule), or have a DLT within the first cycle of treatment to be evaluable for dose escalation decisions.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 5; 100mg
Dose escalation to 100 mg after initial cohort (Cohort 1) after a minimum of 1 cycle of treatment, defined as receiving ≥75% of KPT-9274 doses during Cycle 1 (e.g., ≥9 of 12 doses in the 3 doses/week schedule), or have a DLT within the first cycle of treatment to be evaluable for dose escalation decisions.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
|---|---|---|---|---|---|---|
|
Count of Participants Who Did Not Experience a DLT Are Listed in the Outcome Measure Data Table
|
0 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
De-escalation Cohort; 20mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 1; 30 mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 5 deaths
Cohort 2; 40mg
Serious events: 3 serious events
Other events: 7 other events
Deaths: 6 deaths
Cohort 3; 60mg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths
Cohort 4; 80mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 5; 100mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
De-escalation Cohort; 20mg
For the purposes of dose escalation decisions, a standard 3+3 dose escalation design will be used.The initial cohort, Cohort 1, will consist of 3 enrolled patients who will be treated at 30 mg. If the MTD is exceeded at cohort 1, de-escalation to cohort 0 (20 mg) will occur. If the MTD is not exceeded in cohort 1, dose escalation will continue based on a standard 3+3 design at the dose levels.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 1; 30 mg
n=5 participants at risk
The initial cohort, Cohort 1, will consist of 3 enrolled patients who will be treated at 30 mg.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 2; 40mg
n=7 participants at risk
Dose escalation to 40 mg after initial cohort (Cohort 1) after a minimum of 1 cycle of treatment, defined as receiving ≥75% of KPT-9274 doses during Cycle 1 (e.g., ≥9 of 12 doses in the 3 doses/week schedule), or have a DLT within the first cycle of treatment to be evaluable for dose escalation decisions.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 3; 60mg
n=4 participants at risk
Dose escalation to 60 mg after initial cohort (Cohort 1) after a minimum of 1 cycle of treatment, defined as receiving ≥75% of KPT-9274 doses during Cycle 1 (e.g., ≥9 of 12 doses in the 3 doses/week schedule), or have a DLT within the first cycle of treatment to be evaluable for dose escalation decisions.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 4; 80mg
Dose escalation to 80 mg after initial cohort (Cohort 1) after a minimum of 1 cycle of treatment, defined as receiving ≥75% of KPT-9274 doses during Cycle 1 (e.g., ≥9 of 12 doses in the 3 doses/week schedule), or have a DLT within the first cycle of treatment to be evaluable for dose escalation decisions.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 5; 100mg
Dose escalation to 100 mg after initial cohort (Cohort 1) after a minimum of 1 cycle of treatment, defined as receiving ≥75% of KPT-9274 doses during Cycle 1 (e.g., ≥9 of 12 doses in the 3 doses/week schedule), or have a DLT within the first cycle of treatment to be evaluable for dose escalation decisions.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
28.6%
2/7 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Infections and infestations - Other, specify
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Sepsis
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Lung infection
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 3 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
50.0%
2/4 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
General disorders
Multi-organ failure
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
Other adverse events
| Measure |
De-escalation Cohort; 20mg
For the purposes of dose escalation decisions, a standard 3+3 dose escalation design will be used.The initial cohort, Cohort 1, will consist of 3 enrolled patients who will be treated at 30 mg. If the MTD is exceeded at cohort 1, de-escalation to cohort 0 (20 mg) will occur. If the MTD is not exceeded in cohort 1, dose escalation will continue based on a standard 3+3 design at the dose levels.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 1; 30 mg
n=5 participants at risk
The initial cohort, Cohort 1, will consist of 3 enrolled patients who will be treated at 30 mg.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 2; 40mg
n=7 participants at risk
Dose escalation to 40 mg after initial cohort (Cohort 1) after a minimum of 1 cycle of treatment, defined as receiving ≥75% of KPT-9274 doses during Cycle 1 (e.g., ≥9 of 12 doses in the 3 doses/week schedule), or have a DLT within the first cycle of treatment to be evaluable for dose escalation decisions.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 3; 60mg
n=4 participants at risk
Dose escalation to 60 mg after initial cohort (Cohort 1) after a minimum of 1 cycle of treatment, defined as receiving ≥75% of KPT-9274 doses during Cycle 1 (e.g., ≥9 of 12 doses in the 3 doses/week schedule), or have a DLT within the first cycle of treatment to be evaluable for dose escalation decisions.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 4; 80mg
Dose escalation to 80 mg after initial cohort (Cohort 1) after a minimum of 1 cycle of treatment, defined as receiving ≥75% of KPT-9274 doses during Cycle 1 (e.g., ≥9 of 12 doses in the 3 doses/week schedule), or have a DLT within the first cycle of treatment to be evaluable for dose escalation decisions.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
Cohort 5; 100mg
Dose escalation to 100 mg after initial cohort (Cohort 1) after a minimum of 1 cycle of treatment, defined as receiving ≥75% of KPT-9274 doses during Cycle 1 (e.g., ≥9 of 12 doses in the 3 doses/week schedule), or have a DLT within the first cycle of treatment to be evaluable for dose escalation decisions.
KPT-9274: KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
|
|---|---|---|---|---|---|---|
|
Investigations
Investigations - Other, specify
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Investigations - Other, specify
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Lung infection
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Skin infection
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Investigations
Platelet Count Decrease
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
80.0%
4/5 • Number of events 34 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
71.4%
5/7 • Number of events 13 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
60.0%
3/5 • Number of events 5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
28.6%
2/7 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Nausea
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Investigations
Neutrophil count decreased
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
40.0%
2/5 • Number of events 12 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
42.9%
3/7 • Number of events 6 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Oral hemorrhage
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Stomach pain
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Vascular disorders
Thromboembolic event
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Sepsis
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
28.6%
2/7 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Cardiac disorders
Sinus tachycardia
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Thrush
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Investigations
Alkaline phosphatase increased
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Blood and lymphatic system disorders
Anemia
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
40.0%
2/5 • Number of events 16 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
57.1%
4/7 • Number of events 16 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Anorexia
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
40.0%
2/5 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
57.1%
4/7 • Number of events 5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
75.0%
3/4 • Number of events 4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Bacteremia
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Investigations
Blood bicarbonate decreased
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Investigations
Blood bilirubin increased
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
40.0%
2/5 • Number of events 4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Investigations
Blood lactate dehydrogenase increased
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
40.0%
2/5 • Number of events 3 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Bruising
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Cardiac disorders
Cardiac arrest
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Constipation
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
40.0%
2/5 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
28.6%
2/7 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
General disorders
Cough
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Renal and urinary disorders
Cystitis noninfective
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Psychiatric disorders
Depression
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Device related infection
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Diarrhea
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
42.9%
3/7 • Number of events 3 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Immune system disorders
Dizziness
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
28.6%
2/7 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Eczema
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
General disorders
Edema limbs
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
42.9%
3/7 • Number of events 3 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
75.0%
3/4 • Number of events 5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Eye disorders
Eye disorders - Other, specify
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Fall
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
General disorders
Fatigue
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
80.0%
4/5 • Number of events 5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
42.9%
3/7 • Number of events 3 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
General disorders
Generalized edema
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Psychiatric disorders
Hallucinations
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
28.6%
2/7 • Number of events 3 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
28.6%
2/7 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 3 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
71.4%
5/7 • Number of events 5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
75.0%
3/4 • Number of events 4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hypokalemia
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
42.9%
3/7 • Number of events 3 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 3 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
28.6%
2/7 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hyponatremia
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
40.0%
2/5 • Number of events 3 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
28.6%
2/7 • Number of events 3 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
50.0%
2/4 • Number of events 2 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Vascular disorders
Hypotension
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Ileus
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Investigations
Thyroid stimulating hormone increased
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Tooth infection
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Urinary tract infection
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Investigations
Urine output decreased
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
14.3%
1/7 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Vomiting
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Investigations
Weight loss
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 1 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/7 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
|
Investigations
White blood cell decreased
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
20.0%
1/5 • Number of events 5 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
42.9%
3/7 • Number of events 6 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
—
0/0 • Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study drug through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first. This is patient-dependent based on the # of cycles they complete, with an average of 1 cycle completed or approximately 58 days to report Adverse Events.
1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place