Trial Outcomes & Findings for MLN0128 in Recurrent/Metastatic Merkel Cell Carcinoma (NCT NCT02514824)
NCT ID: NCT02514824
Last Updated: 2020-12-29
Results Overview
The MLN01283 MTD is determined by the number of participants who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached but the highest dose received may be the Recommended Phase II Dose (RP2D).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
9 participants
Primary outcome timeframe
The observation period for DLT evaluation was the first 28 days (cycle 1) of treatment.
Results posted on
2020-12-29
Participant Flow
Participants enrolled from October 2015 through March 2017.
Participant milestones
| Measure |
Dose Level 1: MLN01283 3 mg (Phase 1)
Phase 1 dose level 1 participants receive MLN01283 3mg orally once daily of a 28 day cycle.
Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
|
Dose Level 2: MLN01283 4 mg (Phase 1)
Phase 1 dose level 2 participants receive MLN01283 4 mg orally once daily of a 28 day cycle.
Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
|
Dose Level 3: MLN01283 5 mg (Phase 1)
Phase 1 dose level 3 participants receive MLN01283 5 mg orally once daily of a 28 day cycle.
Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
|
MLN01283 RP2D (Phase 2)
Phase 2 participants receive MLN01283 at the recommended phase 2 dose (RP2D) orally once daily of a 28 day cycle.
Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
0
|
0
|
|
Overall Study
Evaluable for Dose-limiting Toxicity
|
3
|
5
|
0
|
0
|
|
Overall Study
COMPLETED
|
3
|
4
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Dose Level 1: MLN01283 3 mg (Phase 1)
Phase 1 dose level 1 participants receive MLN01283 3mg orally once daily of a 28 day cycle.
Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
|
Dose Level 2: MLN01283 4 mg (Phase 1)
Phase 1 dose level 2 participants receive MLN01283 4 mg orally once daily of a 28 day cycle.
Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
|
Dose Level 3: MLN01283 5 mg (Phase 1)
Phase 1 dose level 3 participants receive MLN01283 5 mg orally once daily of a 28 day cycle.
Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
|
MLN01283 RP2D (Phase 2)
Phase 2 participants receive MLN01283 at the recommended phase 2 dose (RP2D) orally once daily of a 28 day cycle.
Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Overall Study
Dose-Limiting Toxicity
|
0
|
1
|
0
|
0
|
Baseline Characteristics
MLN0128 in Recurrent/Metastatic Merkel Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Dose Level 1: MLN01283 3 mg (Phase 1)
n=4 Participants
Phase 1 dose level 1 participants receive MLN01283 3mg orally once daily of a 28 day cycle.
Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
|
Dose Level 2: MLN01283 4 mg (Phase 1)
n=5 Participants
Phase 1 dose level 2 participants receive MLN01283 4 mg orally once daily of a 28 day cycle.
Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
69 years
n=7 Participants
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The observation period for DLT evaluation was the first 28 days (cycle 1) of treatment.Population: All P1 participants who received at least one dose of the study drug were evaluable for the DLT analysis. Participants who discontinued study treatment prior to end of cycle 1 for reason other than dose-limiting toxicity were replaced.
The MLN01283 MTD is determined by the number of participants who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached but the highest dose received may be the Recommended Phase II Dose (RP2D).
Outcome measures
| Measure |
All Phase 1 Participants
n=8 Participants
Phase 1 participants received MLN01283 according to the established dose escalation schedule.
Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
|
Dose Level 2: MLN01283 4 mg (Phase 1)
Phase 1 dose level 2 participants receive MLN01283 4 mg orally once daily of a 28 day cycle.
Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
|
|---|---|---|
|
MLN01283 Maximum Tolerated Dose (MTD) [Phase I]
|
3 mg
|
—
|
PRIMARY outcome
Timeframe: The observation period for DLT evaluation was the first 28 days (cycle 1) of treatment.Population: All P1 participants who received at least one dose of the study drug were evaluable for the DLT analysis. Participants who discontinued study treatment prior to end of cycle 1 for reason other than dose-limiting toxicity were replaced.
A DLT was defined as an adverse event (AE) assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications meets any of the following criteria including but not limited to: grade (G) 4-5 AEs, G3 thrombocytopenia, neutropenia, AST, ALT, serum creatinine or total bilirubin 2 to 3 x upper limit normal (ULN), aymptomatic amylase and/or lipase lasting \>7 consecutive days; febrile neutropenia; G3 cardiac, hyperglycemia, mood alteration; G2 pancreatitis; G2 hyperglycemia unresolved within 14 days; G2 mood alteration unresolved in 14 days despite medical treatment; Dose interruption \>21 days due to G2 dematologic; one grade level increase neurotoxicity.
Outcome measures
| Measure |
All Phase 1 Participants
n=3 Participants
Phase 1 participants received MLN01283 according to the established dose escalation schedule.
Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
|
Dose Level 2: MLN01283 4 mg (Phase 1)
n=5 Participants
Phase 1 dose level 2 participants receive MLN01283 4 mg orally once daily of a 28 day cycle.
Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
|
|---|---|---|
|
Dose Limiting Toxicity (DLT) [Phase I]
|
0 Participants
|
2 Participants
|
POST_HOC outcome
Timeframe: Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.Objective response is defined as achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. For target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD.
Outcome measures
| Measure |
All Phase 1 Participants
n=4 Participants
Phase 1 participants received MLN01283 according to the established dose escalation schedule.
Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
|
Dose Level 2: MLN01283 4 mg (Phase 1)
n=5 Participants
Phase 1 dose level 2 participants receive MLN01283 4 mg orally once daily of a 28 day cycle.
Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
|
|---|---|---|
|
Number of Participants With Objective Response (OR) [Phase 1]
|
0 Participants
|
0 Participants
|
Adverse Events
Dose Level 1: MLN01283 3 mg (Phase 1)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 3 deaths
Dose Level 2: MLN01283 4 mg (Phase 1)
Serious events: 3 serious events
Other events: 5 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Dose Level 1: MLN01283 3 mg (Phase 1)
n=4 participants at risk
Phase 1 dose level 1 participants receive MLN01283 3mg orally once daily of a 28 day cycle.
Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
|
Dose Level 2: MLN01283 4 mg (Phase 1)
n=5 participants at risk
Phase 1 dose level 2 participants receive MLN01283 4 mg orally once daily of a 28 day cycle.
Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
Other adverse events
| Measure |
Dose Level 1: MLN01283 3 mg (Phase 1)
n=4 participants at risk
Phase 1 dose level 1 participants receive MLN01283 3mg orally once daily of a 28 day cycle.
Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
|
Dose Level 2: MLN01283 4 mg (Phase 1)
n=5 participants at risk
Phase 1 dose level 2 participants receive MLN01283 4 mg orally once daily of a 28 day cycle.
Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
1/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
40.0%
2/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
40.0%
2/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
60.0%
3/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
CPK increased
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Creatinine increased
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
40.0%
2/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
40.0%
2/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Fall
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Fatigue
|
75.0%
3/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
40.0%
2/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
25.0%
1/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
40.0%
2/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
2/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
60.0%
3/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
25.0%
1/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
1/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
40.0%
2/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
1/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
40.0%
2/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
40.0%
2/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infections and infestations - Other
|
25.0%
1/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
80.0%
4/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Pain
|
25.0%
1/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
25.0%
1/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
2/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
25.0%
1/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Skin infection
|
25.0%
1/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Upper respiratory infection
|
25.0%
1/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Urinary urgency
|
25.0%
1/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
40.0%
2/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Weight loss
|
25.0%
1/4 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
60.0%
3/5 • Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place