Trial Outcomes & Findings for Savolitinib in Treating Patients With Recurrent or Refractory Primary CNS Tumors (NCT NCT03598244)
NCT ID: NCT03598244
Last Updated: 2026-07-30
Results Overview
The maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of savolitinib were determined using a Rolling-6 Phase I dose-escalation design. Dose escalation was conducted in cohorts of two to six participants, starting at Dose Level 1. The MTD was defined based on the occurrence of dose-limiting toxicities during the dose-finding period (Course 1: 28 days) according to protocol-specified criteria. No intra-patient dose escalation was permitted. Participants were considered evaluable for dose-limiting toxicity assessment if they received the required dose of study drug and completed the dose-limiting toxicity observation period or experienced a dose-limiting toxicity during that period.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
41 participants
Primary outcome timeframe
Up to 30 days post treatment initiation
Results posted on
2026-07-30
Participant Flow
41 patients have been enrolled, including 35 patients on the Phase 1 and PK cohort and 6 patients on the efficacy expansion cohort. In the Phase 1 and PK cohort, the number of enrolled patients at dose level 0 through dose level 3 are 6, 6, 7, and 16, respectively. Of 16 patients at dose level 3, one patient was deemed ineligible due to BSA value, and another patient did not start protocol treatment due to neurological decline.
Participant milestones
| Measure |
Phase 1 and PK Cohort:Treatment (Savolitinib) Dose Level 0: 75 mg/m2
Patients receive savolitinib PO QD at dose Level 0: 75 mg/m2 in the Phase 1 and PK cohort.
|
Phase 1 and PK Cohort: Treatment (Savolitinib) Dose Level 1: 150 mg/m2
Patients receive savolitinib PO QD at dose Level 1: 150 mg/m2 in the Phase 1 and PK cohort.
|
Phase 1 and PK Cohort: Treatment (Savolitinib) Dose Level 2: 240 mg/m2
Patients receive savolitinib PO QD at dose Level 2: 240 mg/m2 in the Phase 1 and PK cohort.
|
Phase 1 and PK Cohort: Treatment (Savolitinib) Dose Level 3: 350 mg/m2
Patients receive savolitinib PO QD at dose Level 3: 350 mg/m2 in the Phase 1 and PK cohort.
|
Efficacy Expansion Cohort: Treatment (Savolitinib) Dose Level 3: 350 mg/m2
Patients in the efficacy expansion cohort receive savolitinib PO QD at dose level 3 (350 mg/m²).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
7
|
16
|
6
|
|
Overall Study
Completed
|
6
|
6
|
7
|
14
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
7
|
14
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Phase 1 and PK Cohort:Treatment (Savolitinib) Dose Level 0: 75 mg/m2
Patients receive savolitinib PO QD at dose Level 0: 75 mg/m2 in the Phase 1 and PK cohort.
|
Phase 1 and PK Cohort: Treatment (Savolitinib) Dose Level 1: 150 mg/m2
Patients receive savolitinib PO QD at dose Level 1: 150 mg/m2 in the Phase 1 and PK cohort.
|
Phase 1 and PK Cohort: Treatment (Savolitinib) Dose Level 2: 240 mg/m2
Patients receive savolitinib PO QD at dose Level 2: 240 mg/m2 in the Phase 1 and PK cohort.
|
Phase 1 and PK Cohort: Treatment (Savolitinib) Dose Level 3: 350 mg/m2
Patients receive savolitinib PO QD at dose Level 3: 350 mg/m2 in the Phase 1 and PK cohort.
|
Efficacy Expansion Cohort: Treatment (Savolitinib) Dose Level 3: 350 mg/m2
Patients in the efficacy expansion cohort receive savolitinib PO QD at dose level 3 (350 mg/m²).
|
|---|---|---|---|---|---|
|
Overall Study
ineligible
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
did not start protocol treatment due to neurological decline
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
one ineligible subject was not included
Baseline characteristics by cohort
| Measure |
Phase 1 and PK Cohort:Treatment (Savolitinib) Dose Level 0: 75 mg/m2
n=6 Participants
Patients receive savolitinib PO QD at dose Level 0: 75 mg/m2 in the Phase 1 and PK cohort.
|
Phase 1 and PK Cohort: Treatment (Savolitinib) Dose Level 1: 150 mg/m2
n=6 Participants
Patients receive savolitinib PO QD at dose Level 1: 150 mg/m2 in the Phase 1 and PK cohort.
|
Phase 1 and PK Cohort: Treatment (Savolitinib) Dose Level 2: 240 mg/m2
n=7 Participants
Patients receive savolitinib PO QD at dose Level 2: 240 mg/m2 in the Phase 1 and PK cohort.
|
Phase 1 and PK Cohort: Treatment (Savolitinib) Dose Level 3: 350 mg/m2
n=15 Participants
Patients receive savolitinib PO QD at dose Level 3: 350 mg/m2 in the Phase 1 and PK cohort.
|
Efficacy Expansion Cohort: Treatment (Savolitinib) Dose Level 3: 350 mg/m2
n=6 Participants
Patients receive savolitinib PO QD at dose Level 3: 350 mg/m2 in the efficacy expansion cohort.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
16.5 Years
n=20 Participants • one ineligible subject was not included
|
11.6 Years
n=20 Participants • one ineligible subject was not included
|
13.1 Years
n=40 Participants • one ineligible subject was not included
|
8.8 Years
n=5 Participants • one ineligible subject was not included
|
11.6 Years
n=9 Participants • one ineligible subject was not included
|
12.3 Years
n=6 Participants • one ineligible subject was not included
|
|
Sex: Female, Male
Female
|
3 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
9 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
19 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=9 Participants
|
21 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=9 Participants
|
21 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
12 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
8 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
9 Participants
n=5 Participants
|
4 Participants
n=9 Participants
|
26 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days post treatment initiationPopulation: A total of 41 participants were enrolled: 35 in the Phase I dose-escalation and PK expansion cohorts and 6 in the efficacy expansion cohort. Twenty-eight participants were evaluable for dose finding. Seven were not evaluable due to insufficient study drug exposure during the DLT observation period (n=5), lack of neurological stability prior to treatment (n=1), or ineligibility (n=1). The efficacy expansion cohort was enrolled after MTD determination.
The maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of savolitinib were determined using a Rolling-6 Phase I dose-escalation design. Dose escalation was conducted in cohorts of two to six participants, starting at Dose Level 1. The MTD was defined based on the occurrence of dose-limiting toxicities during the dose-finding period (Course 1: 28 days) according to protocol-specified criteria. No intra-patient dose escalation was permitted. Participants were considered evaluable for dose-limiting toxicity assessment if they received the required dose of study drug and completed the dose-limiting toxicity observation period or experienced a dose-limiting toxicity during that period.
Outcome measures
| Measure |
Treatment (Savolitinib) Dose Level 1: 150 mg/m2
Patients receive savolitinib PO QD at dose Level 1: 150 mg/m2.
|
Treatment (Savolitinib) Dose Level 2: 240 mg/m2
Patients receive savolitinib PO QD at dose Level 2: 240 mg/m2.
|
Treatment (Savolitinib) Dose Level 3: 350 mg/m2
Patients receive savolitinib PO QD at dose Level 3: 350 mg/m2.
|
Treatment (Savolitinib) Dose Level 0: 75 mg/m2
n=28 Participants
Patients receive savolitinib PO QD at dose Level 0: 75 mg/m2.
|
|---|---|---|---|---|
|
The Maximum Tolerated Dose (MTD) and Recommended Phase II Dose
|
—
|
—
|
—
|
350 mg/m2
|
PRIMARY outcome
Timeframe: Up to 30 days post treatment initiationPopulation: Among the 40 eligible patients enrolled, 28 patients enrolled during the dose-finding phase and were evaluable for dose limiting toxicity assessment.
Dose-limiting toxicity (DLT) was defined as any adverse event at least possibly related to savolitinib occurring during the dose-finding period that met protocol-specified hematologic or non-hematologic criteria, including severe toxicity, treatment delay, dose reduction, or permanent discontinuation.
Outcome measures
| Measure |
Treatment (Savolitinib) Dose Level 1: 150 mg/m2
n=6 Participants
Patients receive savolitinib PO QD at dose Level 1: 150 mg/m2.
|
Treatment (Savolitinib) Dose Level 2: 240 mg/m2
n=6 Participants
Patients receive savolitinib PO QD at dose Level 2: 240 mg/m2.
|
Treatment (Savolitinib) Dose Level 3: 350 mg/m2
n=12 Participants
Patients receive savolitinib PO QD at dose Level 3: 350 mg/m2.
|
Treatment (Savolitinib) Dose Level 0: 75 mg/m2
n=4 Participants
Patients receive savolitinib PO QD at dose Level 0: 75 mg/m2.
|
|---|---|---|---|---|
|
Number of Patients Who Experienced Dose Limiting Toxicities (DLTs)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: 41 patients have been enrolled, one patient was deemed ineligible due to BSA value and 40 were eligible. To be evaluable for efficacy assessment, patients needed to initiate treatment with savolitinib. There were 39 patients including one patient withdrawal/refusal after beginning protocol therapy met this criterion. One patient did not start protocol treatment due to neurological decline.
The number of objective responses (complete or partial) sustained for at least 8 weeks is counted and reported by dose level. Complete disappearance on MR of all evaluable tumor and mass effect, on a stable or decreasing dose of corticosteroids (or receiving only adrenal replacement doses), accompanied by a stable or improving neurologic examination. Complete response will be confirmed if it is maintained for at least 8 weeks. If CSF was positive, it must be negative. Greater than or equal to 50% reduction in tumor size by bi-dimensional measurement, as compared with the baseline measurements, on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination. Partial response will be confirmed if it is maintained for at least 8 weeks.
Outcome measures
| Measure |
Treatment (Savolitinib) Dose Level 1: 150 mg/m2
n=6 Participants
Patients receive savolitinib PO QD at dose Level 1: 150 mg/m2.
|
Treatment (Savolitinib) Dose Level 2: 240 mg/m2
n=7 Participants
Patients receive savolitinib PO QD at dose Level 2: 240 mg/m2.
|
Treatment (Savolitinib) Dose Level 3: 350 mg/m2
n=20 Participants
Patients receive savolitinib PO QD at dose Level 3: 350 mg/m2.
|
Treatment (Savolitinib) Dose Level 0: 75 mg/m2
n=6 Participants
Patients receive savolitinib PO QD at dose Level 0: 75 mg/m2.
|
|---|---|---|---|---|
|
Number of Patients With Sustained Objective Responses (Complete Response + Partial Response)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 10 days from treatment initiationPopulation: Pharmacokinetic (PK) studies were conducted in 37 participants with 2 occasions correspond to pharmacokinetic measurements obtained on Day 1 and Day 8 for each patient.
This analysis includes savolitinib concentrations from 37 individuals with 2 pharmacokinetic studies (days 1 and 8). The individual posthoc parameter values were used to estimate the area under the concentration curve (AUC0-infinity).
Outcome measures
| Measure |
Treatment (Savolitinib) Dose Level 1: 150 mg/m2
n=4 Participants
Patients receive savolitinib PO QD at dose Level 1: 150 mg/m2.
|
Treatment (Savolitinib) Dose Level 2: 240 mg/m2
n=7 Participants
Patients receive savolitinib PO QD at dose Level 2: 240 mg/m2.
|
Treatment (Savolitinib) Dose Level 3: 350 mg/m2
n=20 Participants
Patients receive savolitinib PO QD at dose Level 3: 350 mg/m2.
|
Treatment (Savolitinib) Dose Level 0: 75 mg/m2
n=6 Participants
Patients receive savolitinib PO QD at dose Level 0: 75 mg/m2.
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters: AUC0-infinity
Day 1
|
6964.81 (mg*hr/L)
Interval 4577.41 to 19811.27
|
11290.49 (mg*hr/L)
Interval 9149.99 to 15727.07
|
15533.97 (mg*hr/L)
Interval 3143.03 to 82988.96
|
3808.59 (mg*hr/L)
Interval 2724.26 to 5376.91
|
|
Pharmacokinetic Parameters: AUC0-infinity
Day 8
|
6635.87 (mg*hr/L)
Interval 4167.75 to 19538.51
|
10125.25 (mg*hr/L)
Interval 8567.86 to 21560.53
|
17273.74 (mg*hr/L)
Interval 9278.16 to 34191.17
|
3215.61 (mg*hr/L)
Interval 1585.16 to 5766.2
|
SECONDARY outcome
Timeframe: up to 10 days from treatment initiationPopulation: Pharmacokinetic (PK) studies were conducted in 37 participants with 2 occasions correspond to pharmacokinetic measurements obtained on Day 1 and Day 8 for each patient.
Pharmacokinetic (PK) studies were conducted in 37 participants, with two PK assessment occasions corresponding to Day 1 and Day 8 for each patient. A one-compartment PK model with first-order absorption was used to describe the concentration-time data. Individual post hoc parameter estimates were then used to derive the maximum concentration (Cmax).
Outcome measures
| Measure |
Treatment (Savolitinib) Dose Level 1: 150 mg/m2
n=4 Participants
Patients receive savolitinib PO QD at dose Level 1: 150 mg/m2.
|
Treatment (Savolitinib) Dose Level 2: 240 mg/m2
n=7 Participants
Patients receive savolitinib PO QD at dose Level 2: 240 mg/m2.
|
Treatment (Savolitinib) Dose Level 3: 350 mg/m2
n=20 Participants
Patients receive savolitinib PO QD at dose Level 3: 350 mg/m2.
|
Treatment (Savolitinib) Dose Level 0: 75 mg/m2
n=6 Participants
Patients receive savolitinib PO QD at dose Level 0: 75 mg/m2.
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters of Interest: Cmax
Day 1
|
1169.06 ng/mL
Interval 604.4 to 2111.32
|
2608.32 ng/mL
Interval 1250.95 to 2911.65
|
2070.49 ng/mL
Interval 406.75 to 12893.2
|
605.59 ng/mL
Interval 508.26 to 1236.15
|
|
Pharmacokinetic Parameters of Interest: Cmax
Day 8
|
1096.00 ng/mL
Interval 639.51 to 1226.89
|
1853.89 ng/mL
Interval 1478.17 to 3493.61
|
2313.20 ng/mL
Interval 978.34 to 4889.2
|
471.24 ng/mL
Interval 315.06 to 830.4
|
SECONDARY outcome
Timeframe: up to 10 days from treatment initiationPopulation: Pharmacokinetic (PK) studies were conducted in 37 participants, with two occasions corresponding to pharmacokinetic measurements obtained on Day 1 and Day 8 for each patient.
This analysis includes savolitinib concentrations from 37 individuals with 2 pharmacokinetic studies (days 1 and 8). A one-compartment PK model with first-order absorption was used to describe the data.
Outcome measures
| Measure |
Treatment (Savolitinib) Dose Level 1: 150 mg/m2
n=4 Participants
Patients receive savolitinib PO QD at dose Level 1: 150 mg/m2.
|
Treatment (Savolitinib) Dose Level 2: 240 mg/m2
n=7 Participants
Patients receive savolitinib PO QD at dose Level 2: 240 mg/m2.
|
Treatment (Savolitinib) Dose Level 3: 350 mg/m2
n=20 Participants
Patients receive savolitinib PO QD at dose Level 3: 350 mg/m2.
|
Treatment (Savolitinib) Dose Level 0: 75 mg/m2
n=6 Participants
Patients receive savolitinib PO QD at dose Level 0: 75 mg/m2.
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters: Clearance/F
Day 1
|
23.00 L/hr/m2
Interval 9.52 to 37.03
|
21.36 L/hr/m2
Interval 14.08 to 27.79
|
23.24 L/hr/m2
Interval 4.3 to 123.56
|
20.96 L/hr/m2
Interval 15.92 to 23.38
|
|
Pharmacokinetic Parameters: Clearance/F
Day 8
|
23.66 L/hr/m2
Interval 9.48 to 41.01
|
24.17 L/hr/m2
Interval 9.37 to 28.47
|
20.04 L/hr/m2
Interval 12.79 to 34.54
|
22.26 L/hr/m2
Interval 16.21 to 40.18
|
SECONDARY outcome
Timeframe: up to 10 days from treatment initiationPopulation: Pharmacokinetic (PK) studies were conducted in 37 participants, with two occasions corresponding to PK measurements obtained on Day 1 and Day 8 for each patient. These PK parameters were estimated using a nonlinear mixed-effects population PK model based on pooled data from all participants receiving Savolitinib across study cohorts. This pooled analysis was pre-specified in the protocol to characterize population-level PK parameters rather than to estimate parameters separately by Arm/Group.
Population PK parameters were estimated using nonlinear mixed-effects modeling. And nonlinear mixed-effects modeling was performed with Monolix (version 2024R1) using the Stochastic Approximation Expectation-Maximization (SAEM) method. Reported values are fixed-effect population estimates for lag time (absorption lag time (Tlag (hrs)).
Outcome measures
| Measure |
Treatment (Savolitinib) Dose Level 1: 150 mg/m2
Patients receive savolitinib PO QD at dose Level 1: 150 mg/m2.
|
Treatment (Savolitinib) Dose Level 2: 240 mg/m2
Patients receive savolitinib PO QD at dose Level 2: 240 mg/m2.
|
Treatment (Savolitinib) Dose Level 3: 350 mg/m2
Patients receive savolitinib PO QD at dose Level 3: 350 mg/m2.
|
Treatment (Savolitinib) Dose Level 0: 75 mg/m2
n=37 Participants
Patients receive savolitinib PO QD at dose Level 0: 75 mg/m2.
|
|---|---|---|---|---|
|
Population Parameters: Fixed-Effect Parameter Estimates: Tlag_pop
|
—
|
—
|
—
|
0.47 hrs
Interval 0.35 to 0.62
|
SECONDARY outcome
Timeframe: up to 10 days from treatment initiationPopulation: Pharmacokinetic (PK) studies were conducted in 37 participants, with two occasions corresponding to PK measurements obtained on Day 1 and Day 8 for each patient. These PK parameters were estimated using a nonlinear mixed-effects population PK model based on pooled data from all participants receiving Savolitinib across study cohorts. This pooled analysis was pre-specified in the protocol to characterize population-level PK parameters rather than to estimate parameters separately by Arm/Group.
Population PK parameters were estimated using nonlinear mixed-effects modeling. And nonlinear mixed-effects modeling was performed with Monolix (version 2024R1) using the Stochastic Approximation Expectation-Maximization (SAEM) method. Reported values are fixed-effect population estimates absorption rate constant (absorption (ka (1/hr))).
Outcome measures
| Measure |
Treatment (Savolitinib) Dose Level 1: 150 mg/m2
Patients receive savolitinib PO QD at dose Level 1: 150 mg/m2.
|
Treatment (Savolitinib) Dose Level 2: 240 mg/m2
Patients receive savolitinib PO QD at dose Level 2: 240 mg/m2.
|
Treatment (Savolitinib) Dose Level 3: 350 mg/m2
Patients receive savolitinib PO QD at dose Level 3: 350 mg/m2.
|
Treatment (Savolitinib) Dose Level 0: 75 mg/m2
n=37 Participants
Patients receive savolitinib PO QD at dose Level 0: 75 mg/m2.
|
|---|---|---|---|---|
|
Population Parameters: Fixed-Effect Parameter Estimates: ka_pop
|
—
|
—
|
—
|
0.23 1/hr
Interval 0.21 to 0.26
|
SECONDARY outcome
Timeframe: up to 10 days from treatment initiationPopulation: Pharmacokinetic (PK) studies were conducted in 37 participants, with two occasions corresponding to PK measurements obtained on Day 1 and Day 8 for each patient. These PK parameters were estimated using a nonlinear mixed-effects population PK model based on pooled data from all participants receiving Savolitinib across study cohorts. This pooled analysis was pre-specified in the protocol to characterize population-level PK parameters rather than to estimate parameters separately by Arm/Group.
Population PK parameters were estimated using nonlinear mixed-effects modeling. And nonlinear mixed-effects modeling was performed with Monolix (version 2024R1) using the Stochastic Approximation Expectation-Maximization (SAEM) method. Reported values are fixed-effect population estimates volume (V/F (L).
Outcome measures
| Measure |
Treatment (Savolitinib) Dose Level 1: 150 mg/m2
Patients receive savolitinib PO QD at dose Level 1: 150 mg/m2.
|
Treatment (Savolitinib) Dose Level 2: 240 mg/m2
Patients receive savolitinib PO QD at dose Level 2: 240 mg/m2.
|
Treatment (Savolitinib) Dose Level 3: 350 mg/m2
Patients receive savolitinib PO QD at dose Level 3: 350 mg/m2.
|
Treatment (Savolitinib) Dose Level 0: 75 mg/m2
n=37 Participants
Patients receive savolitinib PO QD at dose Level 0: 75 mg/m2.
|
|---|---|---|---|---|
|
Population Parameters: Fixed-Effect Parameter Estimates: V_pop
|
—
|
—
|
—
|
17.22 L
Interval 11.78 to 25.16
|
SECONDARY outcome
Timeframe: up to 10 days from treatment initiationPopulation: Pharmacokinetic (PK) studies were conducted in 37 participants, with two occasions corresponding to PK measurements obtained on Day 1 and Day 8 for each patient. These PK parameters were estimated using a nonlinear mixed-effects population PK model based on pooled data from all participants receiving Savolitinib across study cohorts. This pooled analysis was pre-specified in the protocol to characterize population-level PK parameters rather than to estimate parameters separately by Arm/Group.
Population PK parameters were estimated using nonlinear mixed-effects modeling. And nonlinear mixed-effects modeling was performed with Monolix (version 2024R1) using the Stochastic Approximation Expectation-Maximization (SAEM) method. Reported values are fixed-effect population estimates for clearance (CL/F (L/hr) ).
Outcome measures
| Measure |
Treatment (Savolitinib) Dose Level 1: 150 mg/m2
Patients receive savolitinib PO QD at dose Level 1: 150 mg/m2.
|
Treatment (Savolitinib) Dose Level 2: 240 mg/m2
Patients receive savolitinib PO QD at dose Level 2: 240 mg/m2.
|
Treatment (Savolitinib) Dose Level 3: 350 mg/m2
Patients receive savolitinib PO QD at dose Level 3: 350 mg/m2.
|
Treatment (Savolitinib) Dose Level 0: 75 mg/m2
n=37 Participants
Patients receive savolitinib PO QD at dose Level 0: 75 mg/m2.
|
|---|---|---|---|---|
|
Population Parameters: Fixed-Effect Parameter Estimates: Cl_pop
|
—
|
—
|
—
|
20.29 L/hr
Interval 17.51 to 23.51
|
SECONDARY outcome
Timeframe: up to 10 days from treatment initiationPopulation: Pharmacokinetic (PK) studies were conducted in 37 participants, with two occasions corresponding to PK measurements obtained on Day 1 and Day 8 for each patient. These PK parameters were estimated using a nonlinear mixed-effects population PK model based on pooled data from all participants receiving Savolitinib across study cohorts. This pooled analysis was pre-specified in the protocol to characterize population-level PK parameters rather than to estimate parameters separately by Arm/Group.
Reported values are standard deviations of random effects from the nonlinear mixed-effects population pharmacokinetic model. "Omega" represents the standard deviation of between-subject variability (inter-individual variability).
Outcome measures
| Measure |
Treatment (Savolitinib) Dose Level 1: 150 mg/m2
Patients receive savolitinib PO QD at dose Level 1: 150 mg/m2.
|
Treatment (Savolitinib) Dose Level 2: 240 mg/m2
Patients receive savolitinib PO QD at dose Level 2: 240 mg/m2.
|
Treatment (Savolitinib) Dose Level 3: 350 mg/m2
Patients receive savolitinib PO QD at dose Level 3: 350 mg/m2.
|
Treatment (Savolitinib) Dose Level 0: 75 mg/m2
n=37 Participants
Patients receive savolitinib PO QD at dose Level 0: 75 mg/m2.
|
|---|---|---|---|---|
|
Population Parameters: Inter-individual Variability Estimates for Population PK Parameters: omega_Tlag
|
—
|
—
|
—
|
0.61 hrs
Interval 0.38 to 0.99
|
SECONDARY outcome
Timeframe: up to 10 days from treatment initiationPopulation: Pharmacokinetic (PK) studies were conducted in 37 participants, with two occasions corresponding to PK measurements obtained on Day 1 and Day 8 for each patient. These PK parameters were estimated using a nonlinear mixed-effects population PK model based on pooled data from all participants receiving Savolitinib across study cohorts. This pooled analysis was pre-specified in the protocol to characterize population-level PK parameters rather than to estimate parameters separately by Arm/Group.
Reported values are standard deviations of random effects from the nonlinear mixed-effects population pharmacokinetic model. "Omega" represents the standard deviation of between-subject variability (inter-individual variability).
Outcome measures
| Measure |
Treatment (Savolitinib) Dose Level 1: 150 mg/m2
Patients receive savolitinib PO QD at dose Level 1: 150 mg/m2.
|
Treatment (Savolitinib) Dose Level 2: 240 mg/m2
Patients receive savolitinib PO QD at dose Level 2: 240 mg/m2.
|
Treatment (Savolitinib) Dose Level 3: 350 mg/m2
Patients receive savolitinib PO QD at dose Level 3: 350 mg/m2.
|
Treatment (Savolitinib) Dose Level 0: 75 mg/m2
n=37 Participants
Patients receive savolitinib PO QD at dose Level 0: 75 mg/m2.
|
|---|---|---|---|---|
|
Population Parameters: Inter-individual Variability Estimates for Population PK Parameters: omega_ka
|
—
|
—
|
—
|
0.22 1/hr
Interval 0.15 to 0.34
|
SECONDARY outcome
Timeframe: up to 10 days from treatment initiationPopulation: Pharmacokinetic (PK) studies were conducted in 37 participants, with two occasions corresponding to PK measurements obtained on Day 1 and Day 8 for each patient. These PK parameters were estimated using a nonlinear mixed-effects population PK model based on pooled data from all participants receiving Savolitinib across study cohorts. This pooled analysis was pre-specified in the protocol to characterize population-level PK parameters rather than to estimate parameters separately by Arm/Group.
Reported values are standard deviations of random effects from the nonlinear mixed-effects population pharmacokinetic model. "Omega" represents the standard deviation of between-subject variability (inter-individual variability).
Outcome measures
| Measure |
Treatment (Savolitinib) Dose Level 1: 150 mg/m2
Patients receive savolitinib PO QD at dose Level 1: 150 mg/m2.
|
Treatment (Savolitinib) Dose Level 2: 240 mg/m2
Patients receive savolitinib PO QD at dose Level 2: 240 mg/m2.
|
Treatment (Savolitinib) Dose Level 3: 350 mg/m2
Patients receive savolitinib PO QD at dose Level 3: 350 mg/m2.
|
Treatment (Savolitinib) Dose Level 0: 75 mg/m2
n=37 Participants
Patients receive savolitinib PO QD at dose Level 0: 75 mg/m2.
|
|---|---|---|---|---|
|
Population Parameters: Inter-individual Variability Estimates for Population PK Parameters: omega_V
|
—
|
—
|
—
|
0.73 L
Interval 0.42 to 1.27
|
SECONDARY outcome
Timeframe: up to 10 days from treatment initiationPopulation: Pharmacokinetic (PK) studies were conducted in 37 participants, with two occasions corresponding to PK measurements obtained on Day 1 and Day 8 for each patient. These PK parameters were estimated using a nonlinear mixed-effects population PK model based on pooled data from all participants receiving Savolitinib across study cohorts. This pooled analysis was pre-specified in the protocol to characterize population-level PK parameters rather than to estimate parameters separately by Arm/Group.
Reported values are standard deviations of random effects from the nonlinear mixed-effects population pharmacokinetic model. "Omega" represents the standard deviation of between-subject variability (inter-individual variability).
Outcome measures
| Measure |
Treatment (Savolitinib) Dose Level 1: 150 mg/m2
Patients receive savolitinib PO QD at dose Level 1: 150 mg/m2.
|
Treatment (Savolitinib) Dose Level 2: 240 mg/m2
Patients receive savolitinib PO QD at dose Level 2: 240 mg/m2.
|
Treatment (Savolitinib) Dose Level 3: 350 mg/m2
Patients receive savolitinib PO QD at dose Level 3: 350 mg/m2.
|
Treatment (Savolitinib) Dose Level 0: 75 mg/m2
n=37 Participants
Patients receive savolitinib PO QD at dose Level 0: 75 mg/m2.
|
|---|---|---|---|---|
|
Population Parameters: Inter-individual Variability Estimates for Population PK Parameters: omega_Cl
|
—
|
—
|
—
|
0.36 L/hr
Interval 0.22 to 0.57
|
SECONDARY outcome
Timeframe: up to 10 days from treatment initiationPopulation: Pharmacokinetic (PK) studies were conducted in 37 participants, with two occasions corresponding to PK measurements obtained on Day 1 and Day 8 for each patient. These PK parameters were estimated using a nonlinear mixed-effects population PK model based on pooled data from all participants receiving Savolitinib across study cohorts. This pooled analysis was pre-specified in the protocol to characterize population-level PK parameters rather than to estimate parameters separately by Arm/Group.
Reported values are standard deviations of random effects from the nonlinear mixed-effects population pharmacokinetic model. "Gamma" represents the standard deviation of inter-occasion variability. Two occasions correspond to pharmacokinetic measurements obtained on Day 1 and Day 8 for each patient.
Outcome measures
| Measure |
Treatment (Savolitinib) Dose Level 1: 150 mg/m2
Patients receive savolitinib PO QD at dose Level 1: 150 mg/m2.
|
Treatment (Savolitinib) Dose Level 2: 240 mg/m2
Patients receive savolitinib PO QD at dose Level 2: 240 mg/m2.
|
Treatment (Savolitinib) Dose Level 3: 350 mg/m2
Patients receive savolitinib PO QD at dose Level 3: 350 mg/m2.
|
Treatment (Savolitinib) Dose Level 0: 75 mg/m2
n=37 Participants
Patients receive savolitinib PO QD at dose Level 0: 75 mg/m2.
|
|---|---|---|---|---|
|
Population Parameters: Inter-individual Variability Estimates for Population PK Parameters: gamma_Tlag
|
—
|
—
|
—
|
0.65 hrs
Interval 0.49 to 0.88
|
SECONDARY outcome
Timeframe: up to 10 days from treatment initiationPopulation: Pharmacokinetic (PK) studies were conducted in 37 participants, with two occasions corresponding to PK measurements obtained on Day 1 and Day 8 for each patient. These PK parameters were estimated using a nonlinear mixed-effects population PK model based on pooled data from all participants receiving Savolitinib across study cohorts. This pooled analysis was pre-specified in the protocol to characterize population-level PK parameters rather than to estimate parameters separately by Arm/Group.
Reported values are standard deviations of random effects from the nonlinear mixed-effects population pharmacokinetic model. "Gamma" represents the standard deviation of inter-occasion variability. Two occasions correspond to pharmacokinetic measurements obtained on Day 1 and Day 8 for each patient.
Outcome measures
| Measure |
Treatment (Savolitinib) Dose Level 1: 150 mg/m2
Patients receive savolitinib PO QD at dose Level 1: 150 mg/m2.
|
Treatment (Savolitinib) Dose Level 2: 240 mg/m2
Patients receive savolitinib PO QD at dose Level 2: 240 mg/m2.
|
Treatment (Savolitinib) Dose Level 3: 350 mg/m2
Patients receive savolitinib PO QD at dose Level 3: 350 mg/m2.
|
Treatment (Savolitinib) Dose Level 0: 75 mg/m2
n=37 Participants
Patients receive savolitinib PO QD at dose Level 0: 75 mg/m2.
|
|---|---|---|---|---|
|
Population Parameters: Inter-individual Variability Estimates for Population PK Parameters: gamma_ka
|
—
|
—
|
—
|
0.15 1/hr
Interval 0.082 to 0.26
|
SECONDARY outcome
Timeframe: up to 10 days from treatment initiationPopulation: Pharmacokinetic (PK) studies were conducted in 37 participants, with two occasions corresponding to PK measurements obtained on Day 1 and Day 8 for each patient. These PK parameters were estimated using a nonlinear mixed-effects population PK model based on pooled data from all participants receiving Savolitinib across study cohorts. This pooled analysis was pre-specified in the protocol to characterize population-level PK parameters rather than to estimate parameters separately by Arm/Group.
Reported values are standard deviations of random effects from the nonlinear mixed-effects population pharmacokinetic model. "Gamma" represents the standard deviation of inter-occasion variability. Two occasions correspond to pharmacokinetic measurements obtained on Day 1 and Day 8 for each patient.
Outcome measures
| Measure |
Treatment (Savolitinib) Dose Level 1: 150 mg/m2
Patients receive savolitinib PO QD at dose Level 1: 150 mg/m2.
|
Treatment (Savolitinib) Dose Level 2: 240 mg/m2
Patients receive savolitinib PO QD at dose Level 2: 240 mg/m2.
|
Treatment (Savolitinib) Dose Level 3: 350 mg/m2
Patients receive savolitinib PO QD at dose Level 3: 350 mg/m2.
|
Treatment (Savolitinib) Dose Level 0: 75 mg/m2
n=37 Participants
Patients receive savolitinib PO QD at dose Level 0: 75 mg/m2.
|
|---|---|---|---|---|
|
Population Parameters: Inter-individual Variability Estimates for Population PK Parameters: gamma_V
|
—
|
—
|
—
|
0.92 L
Interval 0.65 to 1.3
|
SECONDARY outcome
Timeframe: up to 10 days from treatment initiationPopulation: Pharmacokinetic (PK) studies were conducted in 37 participants, with two occasions corresponding to PK measurements obtained on Day 1 and Day 8 for each patient. These PK parameters were estimated using a nonlinear mixed-effects population PK model based on pooled data from all participants receiving Savolitinib across study cohorts. This pooled analysis was pre-specified in the protocol to characterize population-level PK parameters rather than to estimate parameters separately by Arm/Group.
Reported values are standard deviations of random effects from the nonlinear mixed-effects population pharmacokinetic model. "Gamma" represents the standard deviation of inter-occasion variability. Two occasions correspond to pharmacokinetic measurements obtained on Day 1 and Day 8 for each patient.
Outcome measures
| Measure |
Treatment (Savolitinib) Dose Level 1: 150 mg/m2
Patients receive savolitinib PO QD at dose Level 1: 150 mg/m2.
|
Treatment (Savolitinib) Dose Level 2: 240 mg/m2
Patients receive savolitinib PO QD at dose Level 2: 240 mg/m2.
|
Treatment (Savolitinib) Dose Level 3: 350 mg/m2
Patients receive savolitinib PO QD at dose Level 3: 350 mg/m2.
|
Treatment (Savolitinib) Dose Level 0: 75 mg/m2
n=37 Participants
Patients receive savolitinib PO QD at dose Level 0: 75 mg/m2.
|
|---|---|---|---|---|
|
Population Parameters: Inter-individual Variability Estimates for Population PK Parameters: gamma_Cl
|
—
|
—
|
—
|
0.32 L/hr
Interval 0.21 to 0.47
|
SECONDARY outcome
Timeframe: Up to 2 yearsTo perform a genomic analysis within the confines of a Phase I study to investigate correlation between response to treatment (as measured by objective response or PFS) and the presence of specific genomic alterations (e.g., MET or HGF amplification, MET mutations, or MET fusion) and/or specific subgroups of disease.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Savolitinib) Dose Level 0: 75 mg/m2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Treatment (Savolitinib) Dose Level 1: 150 mg/m2
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Treatment (Savolitinib) Dose Level 2: 240 mg/m2
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Treatment (Savolitinib) Dose Level 3: 350 mg/m2
Serious events: 4 serious events
Other events: 19 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Treatment (Savolitinib) Dose Level 0: 75 mg/m2
n=6 participants at risk
Patients receive savolitinib PO QD at dose Level 0: 75 mg/m2.
|
Treatment (Savolitinib) Dose Level 1: 150 mg/m2
n=6 participants at risk
Patients receive savolitinib PO QD at dose Level 1: 150 mg/m2.
|
Treatment (Savolitinib) Dose Level 2: 240 mg/m2
n=7 participants at risk
Patients receive savolitinib PO QD at dose Level 2: 240 mg/m2.
|
Treatment (Savolitinib) Dose Level 3: 350 mg/m2
n=21 participants at risk
Patients receive savolitinib PO QD at dose Level 3: 350 mg/m2.
|
|---|---|---|---|---|
|
Investigations
"ALANINE AMINOTRANSFERASE INCREASED"
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
4.8%
1/21 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Investigations
ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
14.3%
1/7 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/21 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
9.5%
2/21 • Number of events 2 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
16.7%
1/6 • Number of events 2 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
9.5%
2/21 • Number of events 4 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
9.5%
2/21 • Number of events 4 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
4.8%
1/21 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Psychiatric disorders
CONFUSION
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
4.8%
1/21 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
Other adverse events
| Measure |
Treatment (Savolitinib) Dose Level 0: 75 mg/m2
n=6 participants at risk
Patients receive savolitinib PO QD at dose Level 0: 75 mg/m2.
|
Treatment (Savolitinib) Dose Level 1: 150 mg/m2
n=6 participants at risk
Patients receive savolitinib PO QD at dose Level 1: 150 mg/m2.
|
Treatment (Savolitinib) Dose Level 2: 240 mg/m2
n=7 participants at risk
Patients receive savolitinib PO QD at dose Level 2: 240 mg/m2.
|
Treatment (Savolitinib) Dose Level 3: 350 mg/m2
n=21 participants at risk
Patients receive savolitinib PO QD at dose Level 3: 350 mg/m2.
|
|---|---|---|---|---|
|
Investigations
"ALANINE AMINOTRANSFERASE INCREASED"
|
16.7%
1/6 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
33.3%
2/6 • Number of events 3 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
28.6%
2/7 • Number of events 3 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
38.1%
8/21 • Number of events 9 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Investigations
HYPOALBUMINEMIA
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
4.8%
1/21 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Gastrointestinal disorders
STOMACH PAIN
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
4.8%
1/21 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Blood and lymphatic system disorders
ANEMIA
|
33.3%
2/6 • Number of events 3 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
50.0%
3/6 • Number of events 3 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
14.3%
1/7 • Number of events 3 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
14.3%
3/21 • Number of events 6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Cardiac disorders
CHEST PAIN - CARDIAC
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
16.7%
1/6 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/21 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Cardiac disorders
QTC ELEVATION
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
4.8%
1/21 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Gastrointestinal disorders
CONSTIPATION
|
16.7%
1/6 • Number of events 2 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
14.3%
3/21 • Number of events 4 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Gastrointestinal disorders
DIARRHEA
|
16.7%
1/6 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
9.5%
2/21 • Number of events 3 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Gastrointestinal disorders
NAUSEA
|
16.7%
1/6 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
42.9%
3/7 • Number of events 3 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
47.6%
10/21 • Number of events 13 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Gastrointestinal disorders
VOMITING
|
16.7%
1/6 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
16.7%
1/6 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
42.9%
3/7 • Number of events 5 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
57.1%
12/21 • Number of events 16 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
General disorders
EDEMA FACE
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
4.8%
1/21 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
General disorders
EDEMA LIMBS
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
9.5%
2/21 • Number of events 2 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
General disorders
FATIGUE
|
33.3%
2/6 • Number of events 2 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
16.7%
1/6 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
14.3%
1/7 • Number of events 2 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
38.1%
8/21 • Number of events 10 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
General disorders
LOCALIZED EDEMA
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
4.8%
1/21 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Infections and infestations
SALIVARY GLAND INFECTION
|
16.7%
1/6 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/21 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Infections and infestations
THRUSH
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
14.3%
1/7 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/21 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Investigations
"ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED"
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
14.3%
1/7 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/21 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Investigations
"ALKALINE PHOSPHATASE INCREASED"
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
14.3%
1/7 • Number of events 4 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
9.5%
2/21 • Number of events 2 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Investigations
"ASPARTATE AMINOTRANSFERASE INCREASED"
|
16.7%
1/6 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
16.7%
1/6 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
14.3%
1/7 • Number of events 2 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
23.8%
5/21 • Number of events 8 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Investigations
"BLOOD BILIRUBIN INCREASED"
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
16.7%
1/6 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/21 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Investigations
CREATININE INCREASED
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
33.3%
2/6 • Number of events 2 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
4.8%
1/21 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Investigations
"PLATELET COUNT DECREASED"
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
33.3%
2/6 • Number of events 2 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
14.3%
1/7 • Number of events 2 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
4.8%
1/21 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Investigations
"ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED"
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
16.7%
1/6 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
14.3%
1/7 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
14.3%
3/21 • Number of events 5 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Investigations
"ELECTROCARDIOGRAM T WAVE ABNORMAL"
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
16.7%
1/6 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/21 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Investigations
"LYMPHOCYTE COUNT DECREASED"
|
33.3%
2/6 • Number of events 4 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
16.7%
1/6 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
14.3%
1/7 • Number of events 5 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
23.8%
5/21 • Number of events 9 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Investigations
"NEUTROPHIL COUNT DECREASED"
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
23.8%
5/21 • Number of events 9 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Investigations
WEIGHT GAIN
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
9.5%
2/21 • Number of events 3 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Investigations
"WHITE BLOOD CELL DECREASED"
|
16.7%
1/6 • Number of events 2 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
16.7%
1/6 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
14.3%
1/7 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
19.0%
4/21 • Number of events 12 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
14.3%
3/21 • Number of events 3 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
14.3%
3/21 • Number of events 3 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
4.8%
1/21 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
4.8%
1/21 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Metabolism and nutrition disorders
HYPERMAGNESEMIA
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
14.3%
1/7 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/21 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
14.3%
1/7 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
23.8%
5/21 • Number of events 10 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
16.7%
1/6 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
9.5%
2/21 • Number of events 2 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
16.7%
1/6 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/21 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
33.3%
2/6 • Number of events 3 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
16.7%
1/6 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
9.5%
2/21 • Number of events 2 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
16.7%
1/6 • Number of events 2 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/21 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
16.7%
1/6 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
9.5%
2/21 • Number of events 2 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
16.7%
1/6 • Number of events 2 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
16.7%
1/6 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
14.3%
1/7 • Number of events 2 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
9.5%
2/21 • Number of events 3 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Nervous system disorders
DIZZINESS
|
16.7%
1/6 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
4.8%
1/21 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
4.8%
1/21 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Nervous system disorders
DYSPHASIA
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
14.3%
1/7 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/21 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Nervous system disorders
HEADACHE
|
16.7%
1/6 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
9.5%
2/21 • Number of events 2 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Nervous system disorders
HYPERSOMNIA
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
4.8%
1/21 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
4.8%
1/21 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Nervous system disorders
SOMNOLENCE
|
16.7%
1/6 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/21 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Psychiatric disorders
CONFUSION
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
4.8%
1/21 • Number of events 3 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
16.7%
1/6 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/21 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
14.3%
1/7 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
4.8%
1/21 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
16.7%
1/6 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/21 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
4.8%
1/21 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Skin and subcutaneous tissue disorders
RASH ACNEIFORM
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
16.7%
1/6 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/21 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
16.7%
1/6 • Number of events 1 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/7 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
4.8%
1/21 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/6 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
14.3%
1/7 • Number of events 5 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
0.00%
0/21 • From initiation of protocol treatment through study completion (up to 3 years).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AEs) associated with an agent using a uniform presentation of events by body system.
|
Additional Information
Dr. Arzu Onar-Thomas
St.Jude Children's Research Hospital
Phone: 9012182532
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60