Trial Outcomes & Findings for Evaluation of Revumenib in Participants With Colorectal Cancer and Other Solid Tumors (NCT NCT05731947)
NCT ID: NCT05731947
Last Updated: 2026-07-06
Results Overview
DLT was defined as any of the following occurring in Cycle 1: Grade 4 neutropenia (absolute neutrophil count \[ANC\] \<500 cells/mm\^3) unresolved to Grade 2 (ANC \>1500 cells/mm\^3) or baseline for more than 7 consecutive days in the absence of growth factor support, ≥Grade 3 neutropenia (ANC \<1000 cells/mm\^3) with a single temperature of \>38.3°Celsius (101°Fahrenheit) or a sustained temperature of ≥38°Celsius (100.4°Fahrenheit) for more than 1 hour, Grade 4 thrombocytopenia (\<25,000/mm\^3) of any duration, ≥Grade 3 thrombocytopenia (\<50,000/mm\^3) with clinically significant bleeding, Grade 4 anemia (i.e, life-threatening consequences; urgent intervention indicated) or ≥Grade 3 nonhematologic toxicity as defined in Common Terminology Criteria for Adverse Events version 5.0 scale where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, medically significant, Grade 4=Life-threatening and 5=Death.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Day 1 up to Day 28
Results posted on
2026-07-06
Participant Flow
The study consisted of Phase 1 and Phase 2. Phase 1 portion of study consisted of a Phase 1a, dose escalation, and a Phase 1b, signal-seeking expansion in colorectal carcinoma. No participants were enrolled in Phase 2 because pre-defined signals of efficacy were not met in Phase 1b dose expansion cohort. So, study was terminated by sponsor after Phase 1b. Data were collected and reported by treatment arm instead of dose received in Phase 1. No participants rolled over from Phase 1a to Phase 1b.
Participant milestones
| Measure |
Phase 1b: Revumenib 270 mg Tablet
Participants received revumenib 270 mg tablets orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1a: Revumenib 160 mg Tablet or 163 mg Capsule
Participants received revumenib 160 milligrams (mg) tablets or 163 mg capsules orally three times a day (TID) or two times a day (BID) from Day 1 of each 28-day cycle.
|
Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule
Participants received revumenib 220 mg tablets or 226 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule
Participants received revumenib 270 mg tablets or 276 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
3
|
10
|
6
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
22
|
3
|
10
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
22
|
3
|
10
|
6
|
Reasons for withdrawal
| Measure |
Phase 1b: Revumenib 270 mg Tablet
Participants received revumenib 270 mg tablets orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1a: Revumenib 160 mg Tablet or 163 mg Capsule
Participants received revumenib 160 milligrams (mg) tablets or 163 mg capsules orally three times a day (TID) or two times a day (BID) from Day 1 of each 28-day cycle.
|
Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule
Participants received revumenib 220 mg tablets or 226 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule
Participants received revumenib 270 mg tablets or 276 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
|---|---|---|---|---|
|
Overall Study
Death
|
15
|
3
|
8
|
5
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Overall Study
Study terminated by sponsor
|
7
|
0
|
1
|
1
|
Baseline Characteristics
Evaluation of Revumenib in Participants With Colorectal Cancer and Other Solid Tumors
Baseline characteristics by cohort
| Measure |
Phase 1a: Revumenib 160 mg Tablet or 163 mg Capsule
n=3 Participants
Participants received Revumenib 160 mg tablets or 163 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule
n=10 Participants
Participants received Revumenib 220 mg tablets or 226 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule
n=6 Participants
Participants received Revumenib 270 mg tablets or 276 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1b: Revumenib 270 mg Tablet
n=22 Participants
Participants received Revumenib 270 mg tablets orally TID or BID from Day 1 of each 28-day cycle.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
3 Participants
n=568 Participants
|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 9.87 • n=9 Participants
|
57.9 years
STANDARD_DEVIATION 10.37 • n=27 Participants
|
56.5 years
STANDARD_DEVIATION 15.10 • n=267 Participants
|
57.1 years
STANDARD_DEVIATION 14.31 • n=265 Participants
|
57.6 years
STANDARD_DEVIATION 12.92 • n=568 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
10 Participants
n=265 Participants
|
18 Participants
n=568 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
12 Participants
n=265 Participants
|
23 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=9 Participants
|
10 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
17 Participants
n=265 Participants
|
35 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
3 Participants
n=568 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
3 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
19 Participants
n=265 Participants
|
34 Participants
n=568 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 28Population: DLT-evaluable population included all participants with data used for implementing the dose escalation schedule (Phase 1a).
DLT was defined as any of the following occurring in Cycle 1: Grade 4 neutropenia (absolute neutrophil count \[ANC\] \<500 cells/mm\^3) unresolved to Grade 2 (ANC \>1500 cells/mm\^3) or baseline for more than 7 consecutive days in the absence of growth factor support, ≥Grade 3 neutropenia (ANC \<1000 cells/mm\^3) with a single temperature of \>38.3°Celsius (101°Fahrenheit) or a sustained temperature of ≥38°Celsius (100.4°Fahrenheit) for more than 1 hour, Grade 4 thrombocytopenia (\<25,000/mm\^3) of any duration, ≥Grade 3 thrombocytopenia (\<50,000/mm\^3) with clinically significant bleeding, Grade 4 anemia (i.e, life-threatening consequences; urgent intervention indicated) or ≥Grade 3 nonhematologic toxicity as defined in Common Terminology Criteria for Adverse Events version 5.0 scale where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, medically significant, Grade 4=Life-threatening and 5=Death.
Outcome measures
| Measure |
Phase 2
n=3 Participants
No participants were enrolled in the Phase 2 of this study.
|
Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule
n=5 Participants
Participants received Revumenib 220 mg tablets or 226 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule
n=6 Participants
Participants received Revumenib 270 mg tablets or 276 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1b: Revumenib 270 mg Tablet
Participants received Revumenib 270 mg tablets orally TID or BID from Day 1 of each 28-day cycle.
|
|---|---|---|---|---|
|
Phase 1a: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 2.2 yearsPopulation: Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study.
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study intervention, whether or not considered related to the study intervention. TEAEs were defined as those having an onset on or after the first dose of revumenib or a sign, symptom, or a diagnosis that worsened on or after first dose of revumenib but no later than 30 days after the date of the last dose of revumenib. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Outcome measures
| Measure |
Phase 2
n=3 Participants
No participants were enrolled in the Phase 2 of this study.
|
Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule
n=10 Participants
Participants received Revumenib 220 mg tablets or 226 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule
n=6 Participants
Participants received Revumenib 270 mg tablets or 276 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1b: Revumenib 270 mg Tablet
n=22 Participants
Participants received Revumenib 270 mg tablets orally TID or BID from Day 1 of each 28-day cycle.
|
|---|---|---|---|---|
|
Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
3 Participants
|
8 Participants
|
6 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: Up to 2.2 yearsPopulation: Response evaluable population included all treated participants who had at least 1 post-baseline disease assessment or discontinued treatment due to clinical disease progression.
DCR was defined as the percentage of participants with objective evidence of confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) according to Response Evaluation in Solid Tumors (RECIST) version 1.1 criteria as assessed by the investigator. CR=disappearance of all target lesions; disappearance of non-target lesions. PR=At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. PD=At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.
Outcome measures
| Measure |
Phase 2
n=3 Participants
No participants were enrolled in the Phase 2 of this study.
|
Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule
n=8 Participants
Participants received Revumenib 220 mg tablets or 226 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule
n=6 Participants
Participants received Revumenib 270 mg tablets or 276 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1b: Revumenib 270 mg Tablet
n=20 Participants
Participants received Revumenib 270 mg tablets orally TID or BID from Day 1 of each 28-day cycle.
|
|---|---|---|---|---|
|
Phase 1: Disease Control Rate (DCR)
|
0 percentage of participants
Interval 0.0 to 70.8
|
25.0 percentage of participants
Interval 3.2 to 65.1
|
33.3 percentage of participants
Interval 4.3 to 77.7
|
10.0 percentage of participants
Interval 1.2 to 31.7
|
PRIMARY outcome
Timeframe: Up to 2.2 yearsPopulation: Response evaluable population included all treated participants who had at least 1 post-baseline disease assessment or discontinued treatment due to clinical disease progression.
ORR was defined as the percentage of participants who achieved a best overall response of PR or CR according to RECIST v1.1 criteria as assessed by the investigator. PR=At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. CR=Disappearance of all target lesions; disappearance of all nontarget lesions.
Outcome measures
| Measure |
Phase 2
n=3 Participants
No participants were enrolled in the Phase 2 of this study.
|
Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule
n=8 Participants
Participants received Revumenib 220 mg tablets or 226 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule
n=6 Participants
Participants received Revumenib 270 mg tablets or 276 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1b: Revumenib 270 mg Tablet
n=20 Participants
Participants received Revumenib 270 mg tablets orally TID or BID from Day 1 of each 28-day cycle.
|
|---|---|---|---|---|
|
Phase 1: Overall Response Rate (ORR)
|
0 percentage of participants
Interval 0.0 to 70.8
|
0 percentage of participants
Interval 0.0 to 36.9
|
0 percentage of participants
Interval 0.0 to 45.9
|
0 percentage of participants
Interval 0.0 to 16.8
|
PRIMARY outcome
Timeframe: Up to 2.2 yearsPopulation: No participants were enrolled in Phase 2 because the pre-defined signals of efficacy were not met in the Phase 1b dose expansion cohort. So, the study was terminated by the sponsor after Phase 1b.
PFS was defined as the time from the first dosing date to the first documented progression or death due to any cause, whichever occurred first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15, Cycle 5 Day 1 (Cycle length=28 days)Population: Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of revumenib and for whom at least 1 valid plasma concentration of revumenib was determined. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at specified time points.
Outcome measures
| Measure |
Phase 2
n=3 Participants
No participants were enrolled in the Phase 2 of this study.
|
Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule
n=7 Participants
Participants received Revumenib 220 mg tablets or 226 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule
n=6 Participants
Participants received Revumenib 270 mg tablets or 276 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1b: Revumenib 270 mg Tablet
Participants received Revumenib 270 mg tablets orally TID or BID from Day 1 of each 28-day cycle.
|
|---|---|---|---|---|
|
Phase 1a: Maximum Plasma Concentration (Cmax) of Revumenib
Cycle 1 Day 7
|
2525 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 26.2
|
3092 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 69.4
|
4078 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 43.2
|
—
|
|
Phase 1a: Maximum Plasma Concentration (Cmax) of Revumenib
Cycle 1 Day 14
|
2174 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 24.5
|
2312 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 73.0
|
3286 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 44.4
|
—
|
|
Phase 1a: Maximum Plasma Concentration (Cmax) of Revumenib
Cycle 2 Day 8
|
3786 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 9.9
|
3436 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 52.2
|
2762 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 99.1
|
—
|
|
Phase 1a: Maximum Plasma Concentration (Cmax) of Revumenib
Cycle 2 Day 15
|
2983 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 10.0
|
3178 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 86.6
|
4404 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 65.7
|
—
|
|
Phase 1a: Maximum Plasma Concentration (Cmax) of Revumenib
Cycle 5 Day 1
|
—
|
1190 nanograms per milliliter (ng/mL)
|
3940 nanograms per milliliter (ng/mL)
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15 (Cycle length=28 days)Population: PK analysis set included all participants who received at least 1 dose of revumenib and for whom at least 1 valid plasma concentration of revumenib was determined. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at specified time points.
Outcome measures
| Measure |
Phase 2
n=19 Participants
No participants were enrolled in the Phase 2 of this study.
|
Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule
Participants received Revumenib 220 mg tablets or 226 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule
Participants received Revumenib 270 mg tablets or 276 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1b: Revumenib 270 mg Tablet
Participants received Revumenib 270 mg tablets orally TID or BID from Day 1 of each 28-day cycle.
|
|---|---|---|---|---|
|
Phase 1b: Maximum Plasma Concentration (Cmax) of Revumenib
Cycle 1 Day 7
|
3225 ng/mL
Geometric Coefficient of Variation 58.6
|
—
|
—
|
—
|
|
Phase 1b: Maximum Plasma Concentration (Cmax) of Revumenib
Cycle 1 Day 14
|
3014 ng/mL
Geometric Coefficient of Variation 56.6
|
—
|
—
|
—
|
|
Phase 1b: Maximum Plasma Concentration (Cmax) of Revumenib
Cycle 2 Day 8
|
3952 ng/mL
Geometric Coefficient of Variation 56.3
|
—
|
—
|
—
|
|
Phase 1b: Maximum Plasma Concentration (Cmax) of Revumenib
Cycle 2 Day 15
|
2237 ng/mL
Geometric Coefficient of Variation 66.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15, Cycle 5 Day 1 (Cycle length=28 days)Population: PK analysis set included all participants who received at least 1 dose of revumenib and for whom at least 1 valid plasma concentration of revumenib was determined. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at specified time points.
Outcome measures
| Measure |
Phase 2
n=3 Participants
No participants were enrolled in the Phase 2 of this study.
|
Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule
n=7 Participants
Participants received Revumenib 220 mg tablets or 226 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule
n=6 Participants
Participants received Revumenib 270 mg tablets or 276 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1b: Revumenib 270 mg Tablet
Participants received Revumenib 270 mg tablets orally TID or BID from Day 1 of each 28-day cycle.
|
|---|---|---|---|---|
|
Phase 1a: Area Under the Plasma Concentration Versus Time Curve (AUC0-t) of Revumenib
Cycle 2 Day 15
|
11700 hours*nanograms/milliliter
Geometric Coefficient of Variation 0.7
|
14840 hours*nanograms/milliliter
Geometric Coefficient of Variation 90.4
|
19580 hours*nanograms/milliliter
Geometric Coefficient of Variation 58.6
|
—
|
|
Phase 1a: Area Under the Plasma Concentration Versus Time Curve (AUC0-t) of Revumenib
Cycle 5 Day 1
|
—
|
6904 hours*nanograms/milliliter
|
22640 hours*nanograms/milliliter
|
—
|
|
Phase 1a: Area Under the Plasma Concentration Versus Time Curve (AUC0-t) of Revumenib
Cycle 2 Day 8
|
14220 hours*nanograms/milliliter
Geometric Coefficient of Variation 3.9
|
16520 hours*nanograms/milliliter
Geometric Coefficient of Variation 61.0
|
13900 hours*nanograms/milliliter
Geometric Coefficient of Variation 91.2
|
—
|
|
Phase 1a: Area Under the Plasma Concentration Versus Time Curve (AUC0-t) of Revumenib
Cycle 1 Day 7
|
12210 hours*nanograms/milliliter
Geometric Coefficient of Variation 25.1
|
14600 hours*nanograms/milliliter
Geometric Coefficient of Variation 53.4
|
17010 hours*nanograms/milliliter
Geometric Coefficient of Variation 37.4
|
—
|
|
Phase 1a: Area Under the Plasma Concentration Versus Time Curve (AUC0-t) of Revumenib
Cycle 1 Day 14
|
9202 hours*nanograms/milliliter
Geometric Coefficient of Variation 21.8
|
11580 hours*nanograms/milliliter
Geometric Coefficient of Variation 77.4
|
16200 hours*nanograms/milliliter
Geometric Coefficient of Variation 48.3
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15, Cycle 5 Day 1 (Cycle length=28 days)Population: PK analysis set included all participants who received at least 1 dose of revumenib and for whom at least 1 valid plasma concentration of revumenib was determined. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at specified time points.
Outcome measures
| Measure |
Phase 2
n=3 Participants
No participants were enrolled in the Phase 2 of this study.
|
Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule
n=7 Participants
Participants received Revumenib 220 mg tablets or 226 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule
n=6 Participants
Participants received Revumenib 270 mg tablets or 276 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1b: Revumenib 270 mg Tablet
Participants received Revumenib 270 mg tablets orally TID or BID from Day 1 of each 28-day cycle.
|
|---|---|---|---|---|
|
Phase 1a: Time to Maximum Plasma Concentration (Tmax) of Revumenib
Cycle 1 Day 7
|
2.117 hours
Interval 2.03 to 4.0
|
1.033 hours
Interval 0.483 to 2.02
|
0.9333 hours
Interval 0.467 to 0.967
|
—
|
|
Phase 1a: Time to Maximum Plasma Concentration (Tmax) of Revumenib
Cycle 1 Day 14
|
2.050 hours
Interval 2.03 to 2.07
|
2.017 hours
Interval 1.95 to 3.8
|
2.050 hours
Interval 1.83 to 3.85
|
—
|
|
Phase 1a: Time to Maximum Plasma Concentration (Tmax) of Revumenib
Cycle 2 Day 8
|
1.242 hours
Interval 0.5 to 1.98
|
0.9333 hours
Interval 0.433 to 1.92
|
0.9833 hours
Interval 0.0 to 2.08
|
—
|
|
Phase 1a: Time to Maximum Plasma Concentration (Tmax) of Revumenib
Cycle 2 Day 15
|
1.242 hours
Interval 0.5 to 1.98
|
0.9667 hours
Interval 0.933 to 1.92
|
1.000 hours
Interval 0.45 to 3.85
|
—
|
|
Phase 1a: Time to Maximum Plasma Concentration (Tmax) of Revumenib
Cycle 5 Day 1
|
—
|
4.000 hours
Interval 4.0 to 4.0
|
3.78 hours
Interval 3.78 to 3.78
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15 (Cycle length=28 days)Population: PK analysis set included all participants who received at least 1 dose of revumenib and for whom at least 1 valid plasma concentration of revumenib was determined. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at specified time points.
Outcome measures
| Measure |
Phase 2
n=19 Participants
No participants were enrolled in the Phase 2 of this study.
|
Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule
Participants received Revumenib 220 mg tablets or 226 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule
Participants received Revumenib 270 mg tablets or 276 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1b: Revumenib 270 mg Tablet
Participants received Revumenib 270 mg tablets orally TID or BID from Day 1 of each 28-day cycle.
|
|---|---|---|---|---|
|
Phase 1b: Time to Maximum Plasma Concentration (Tmax) of Revumenib
Cycle 1 Day 7
|
1.967 hours
Interval 0.5 to 5.75
|
—
|
—
|
—
|
|
Phase 1b: Time to Maximum Plasma Concentration (Tmax) of Revumenib
Cycle 1 Day 14
|
2.150 hours
Interval 1.92 to 4.12
|
—
|
—
|
—
|
|
Phase 1b: Time to Maximum Plasma Concentration (Tmax) of Revumenib
Cycle 2 Day 8
|
1.008 hours
Interval 0.5 to 2.0
|
—
|
—
|
—
|
|
Phase 1b: Time to Maximum Plasma Concentration (Tmax) of Revumenib
Cycle 2 Day 15
|
1.042 hours
Interval 0.0 to 4.03
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15 (Cycle length=28 days)Population: PK analysis set included all participants who received at least 1 dose of revumenib and for whom at least 1 valid plasma concentration of revumenib was determined. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at specified time points.
Outcome measures
| Measure |
Phase 2
n=19 Participants
No participants were enrolled in the Phase 2 of this study.
|
Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule
Participants received Revumenib 220 mg tablets or 226 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule
Participants received Revumenib 270 mg tablets or 276 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1b: Revumenib 270 mg Tablet
Participants received Revumenib 270 mg tablets orally TID or BID from Day 1 of each 28-day cycle.
|
|---|---|---|---|---|
|
Phase 1b: Area Under the Plasma Concentration Versus Time Curve (AUC0-t) of Revumenib
Cycle 1 Day 7
|
16400 h*ng/mL
Geometric Coefficient of Variation 68.2
|
—
|
—
|
—
|
|
Phase 1b: Area Under the Plasma Concentration Versus Time Curve (AUC0-t) of Revumenib
Cycle 1 Day 14
|
16680 h*ng/mL
Geometric Coefficient of Variation 80.6
|
—
|
—
|
—
|
|
Phase 1b: Area Under the Plasma Concentration Versus Time Curve (AUC0-t) of Revumenib
Cycle 2 Day 8
|
15610 h*ng/mL
Geometric Coefficient of Variation 83.0
|
—
|
—
|
—
|
|
Phase 1b: Area Under the Plasma Concentration Versus Time Curve (AUC0-t) of Revumenib
Cycle 2 Day 15
|
10620 h*ng/mL
Geometric Coefficient of Variation 114.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2.2 yearsPopulation: No participants were enrolled in Phase 2 because the pre-defined signals of efficacy were not met in the Phase 1b dose expansion cohort. So, the study was terminated by the sponsor after Phase 1b.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2.2 yearsPopulation: No participants were enrolled in Phase 2 because the pre-defined signals of efficacy were not met in the Phase 1b dose expansion cohort. So, the study was terminated by the sponsor after Phase 1b.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2.2 yearsPopulation: No participants were enrolled in Phase 2 because the pre-defined signals of efficacy were not met in the Phase 1b dose expansion cohort. So, the study was terminated by the sponsor after Phase 1b.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2.2 yearsPopulation: No participants were enrolled in Phase 2 because the pre-defined signals of efficacy were not met in the Phase 1b dose expansion cohort. So, the study was terminated by the sponsor after Phase 1b.
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study intervention, whether or not considered related to the study intervention. TEAEs were defined as those having an onset on or after the first dose of revumenib or a sign, symptom, or a diagnosis that worsened on or after first dose of revumenib but no later than 30 days after the date of the last dose of revumenib. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2.2 yearsPopulation: No participants were enrolled in Phase 2 because the pre-defined signals of efficacy were not met in the Phase 1b dose expansion cohort. So, the study was terminated by the sponsor after Phase 1b.
OS was defined as the time from the date of first dosing of revumenib to death due to any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2.2 yearsPopulation: No participants were enrolled in Phase 2 because the pre-defined signals of efficacy were not met in the Phase 1b dose expansion cohort. So, the study was terminated by the sponsor after Phase 1b.
DCR was defined as the percentage of participants with objective evidence of confirmed CR, confirmed PR, or SD according to RECIST version 1.1 criteria as assessed by blinded radiographic review. CR=disappearance of all target lesions; disappearance of non-target lesions. PR=At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. PD=At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2.2 yearsPopulation: No participants were enrolled in Phase 2 because the pre-defined signals of efficacy were not met in the Phase 1b dose expansion cohort. So, the study was terminated by the sponsor after Phase 1b.
ORR was defined as the percentage of participants who achieved a best overall response of PR or CR according to RECIST v1.1 criteria as assessed by blinded radiographic review. PR=At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. CR=Disappearance of all target lesions; disappearance of all nontarget lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2.2 yearsPopulation: No participants were enrolled in Phase 2 because the pre-defined signals of efficacy were not met in the Phase 1b dose expansion cohort. So, the study was terminated by the sponsor after Phase 1b.
DOR was defined as the time from the first documented response (CR or PR) to the first documented objective PD or death due to any case according to RECIST v1.1 criteria as assessed by blinded radiographic review. PR=At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. CR=Disappearance of all target lesions; disappearance of all nontarget lesions. PD=At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2.2 yearsPopulation: No participants were enrolled in Phase 2 because the pre-defined signals of efficacy were not met in the Phase 1b dose expansion cohort. So, the study was terminated by the sponsor after Phase 1b.
DCR was defined as the percentage of participants with objective evidence of confirmed CR, confirmed PR, or SD according to RECIST version 1.1 criteria as assessed by investigator. CR=disappearance of all target lesions; disappearance of non-target lesions. PR=At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. PD=At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2.2 yearsPopulation: No participants were enrolled in Phase 2 because the pre-defined signals of efficacy were not met in the Phase 1b dose expansion cohort. So, the study was terminated by the sponsor after Phase 1b.
ORR was defined as the percentage of participants who achieved a best overall response of PR or CR according to RECIST v1.1 criteria as assessed by investigator. PR=At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. CR=Disappearance of all target lesions; disappearance of all nontarget lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2.2 yearsPopulation: No participants were enrolled in Phase 2 because the pre-defined signals of efficacy were not met in the Phase 1b dose expansion cohort. So, the study was terminated by the sponsor after Phase 1b.
DOR was defined as the time from the first documented response (CR or PR) to the first documented objective PD or death due to any case according to RECIST v1.1 criteria as assessed by investigator. PR=At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. CR=Disappearance of all target lesions; disappearance of all nontarget lesions. PD=At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.
Outcome measures
Outcome data not reported
Adverse Events
Phase 1a: Revumenib 160 mg Tablet or 163 mg Capsule
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule
Serious events: 2 serious events
Other events: 8 other events
Deaths: 8 deaths
Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule
Serious events: 2 serious events
Other events: 6 other events
Deaths: 5 deaths
Phase 1b: Revumenib 270 mg Tablet
Serious events: 6 serious events
Other events: 22 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Phase 1a: Revumenib 160 mg Tablet or 163 mg Capsule
n=3 participants at risk
Participants received Revumenib 160 mg tablets or 163 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule
n=10 participants at risk
Participants received Revumenib 220 mg tablets or 226 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule
n=6 participants at risk
Participants received Revumenib 270 mg tablets or 276 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1b: Revumenib 270 mg Tablet
n=22 participants at risk
Participants received Revumenib 270 mg tablets orally TID or BID from Day 1 of each 28-day cycle.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
13.6%
3/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
4.5%
1/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
4.5%
1/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
4.5%
1/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
4.5%
1/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
4.5%
1/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
9.1%
2/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
General disorders
Oedema
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
33.3%
1/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
4.5%
1/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Renal and urinary disorders
Acute kidney injury
|
33.3%
1/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
4.5%
1/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
4.5%
1/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
Other adverse events
| Measure |
Phase 1a: Revumenib 160 mg Tablet or 163 mg Capsule
n=3 participants at risk
Participants received Revumenib 160 mg tablets or 163 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule
n=10 participants at risk
Participants received Revumenib 220 mg tablets or 226 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1a: Revumenib 270 mg Tablet or 276 mg Capsule
n=6 participants at risk
Participants received Revumenib 270 mg tablets or 276 mg capsules orally TID or BID from Day 1 of each 28-day cycle.
|
Phase 1b: Revumenib 270 mg Tablet
n=22 participants at risk
Participants received Revumenib 270 mg tablets orally TID or BID from Day 1 of each 28-day cycle.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
4.5%
1/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
20.0%
2/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
22.7%
5/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
9.1%
2/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
9.1%
2/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
20.0%
2/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
40.9%
9/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
18.2%
4/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
9.1%
2/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
13.6%
3/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
13.6%
3/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
9.1%
2/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
83.3%
5/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
45.5%
10/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
20.0%
2/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
66.7%
4/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
36.4%
8/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
1/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
22.7%
5/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
18.2%
4/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
33.3%
2/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
13.6%
3/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
13.6%
3/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
1/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
4.5%
1/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
4.5%
1/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
9.1%
2/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
9.1%
2/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
9.1%
2/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
33.3%
2/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
4.5%
1/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
20.0%
2/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
4.5%
1/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
33.3%
2/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Nervous system disorders
Taste disorder
|
33.3%
1/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
40.0%
4/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
33.3%
2/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
22.7%
5/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
General disorders
Generalised oedema
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
4.5%
1/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
General disorders
Oedema
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
General disorders
Pain
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
4.5%
1/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
20.0%
2/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
4.5%
1/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
50.0%
3/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
22.7%
5/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
1/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
4.5%
1/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
9.1%
2/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
33.3%
1/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
9.1%
2/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
33.3%
1/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
9.1%
2/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
1/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
30.0%
3/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
33.3%
2/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
18.2%
4/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Infections and infestations
Enterobacter infection
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Infections and infestations
Eye infection
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Infections and infestations
Herpes zoster
|
33.3%
1/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
4.5%
1/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
18.2%
4/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
9.1%
2/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
4.5%
1/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
4.5%
1/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Blood and lymphatic system disorders
Leukopenia
|
33.3%
1/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
18.2%
4/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
4.5%
1/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
13.6%
3/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
4.5%
1/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary pain
|
33.3%
1/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
4.5%
1/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Renal and urinary disorders
Renal vein thrombosis
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
4.5%
1/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Psychiatric disorders
Flat affect
|
33.3%
1/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
9.1%
2/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
10.0%
1/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/3 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/10 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
16.7%
1/6 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
0.00%
0/22 • Up to 2.2 years
Safety population consisted of all enrolled participants who received at least 1 dose of study treatment during the study. Safety data were collected and reported by treatment arm instead of dose received in Phase 1.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of the results of the multi-center Study shall not be made before the first multi-site publication by Sponsor or Publications Committee. No Public Presentation by Institution or Investigator will be made until Study Documentation/Results from all sites are received and analyzed by Sponsor. Separate publication by Investigator will be delayed for a specified period time until the initial publication by Committee or Sponsor, or a determination is made not to make such publication.
- Publication restrictions are in place
Restriction type: OTHER