Trial Outcomes & Findings for Merestinib In Non-Small Cell Lung Cancer And Solid Tumors (NCT NCT02920996)
NCT ID: NCT02920996
Last Updated: 2024-04-11
Results Overview
ORR was defined as the proportion of participants achieving complete response (CR) or partial response (PR) as best response on treatment in MET Exon 14 Cohort based on RECISTv1.1 criteria.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
ORR evaluation starting at cycle 2 day 28 and at the end of every 2 cycles of treatment thereafter. The median treatment duration is 1.20 months with range (0.26 months - 28.81 months).
Results posted on
2024-04-11
Participant Flow
Participants enrolled between December 2016 to November 2019.
Participant milestones
| Measure |
NSCLC (Met Exon 14 Mutation)
Merestinib: Oral, predetermined dosage of 120mg per protocol, once daily per 28 day treatment cycle
|
Solid Tumor (NTRK1,2,3 Rearrangement)
Merestinib: Oral, predetermined dosage of 120 mg per protocol, once daily per 28 day treatment cycle
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
12
|
0
|
Reasons for withdrawal
| Measure |
NSCLC (Met Exon 14 Mutation)
Merestinib: Oral, predetermined dosage of 120mg per protocol, once daily per 28 day treatment cycle
|
Solid Tumor (NTRK1,2,3 Rearrangement)
Merestinib: Oral, predetermined dosage of 120 mg per protocol, once daily per 28 day treatment cycle
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Missing
|
1
|
0
|
|
Overall Study
Subject Non-Compliance
|
1
|
0
|
Baseline Characteristics
Merestinib In Non-Small Cell Lung Cancer And Solid Tumors
Baseline characteristics by cohort
| Measure |
NSCLC (Met Exon 14 Mutation)
n=12 Participants
Merestinib: Oral, predetermined dosage of 120mg per protocol, once daily per 28 day treatment cycle
|
Solid Tumor (NTRK1,2,3 Rearrangement)
Merestinib: Oral, predetermined dosage of 120mg per protocol, once daily per 28 day treatment cycle
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
—
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
—
|
9 Participants
n=206 Participants
|
|
Age, Continuous
|
69.13 years
STANDARD_DEVIATION 5.75 • n=99 Participants
|
—
|
69.13 years
STANDARD_DEVIATION 5.75 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
—
|
9 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
—
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
—
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
—
|
12 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: ORR evaluation starting at cycle 2 day 28 and at the end of every 2 cycles of treatment thereafter. The median treatment duration is 1.20 months with range (0.26 months - 28.81 months).Population: The analysis population is comprised of eligible and treated patients.
ORR was defined as the proportion of participants achieving complete response (CR) or partial response (PR) as best response on treatment in MET Exon 14 Cohort based on RECISTv1.1 criteria.
Outcome measures
| Measure |
NSCLC (Met Exon 14 Mutation)
n=12 Participants
Merestinib: Oral, predetermined dosage of 120mg per protocol, once daily per 28 day treatment cycle
|
|---|---|
|
Overall Response Rate (ORR) - MET Exon 14 Cohort
|
0.083 proportion of paticipants
Interval 0.002 to 0.4643
|
SECONDARY outcome
Timeframe: Survival data collection in long-term follow-up every 3 months. Median follow-up for survival is of 24.28 months with range (0.46 months - 32.13 months).OS based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive.
Outcome measures
| Measure |
NSCLC (Met Exon 14 Mutation)
n=12 Participants
Merestinib: Oral, predetermined dosage of 120mg per protocol, once daily per 28 day treatment cycle
|
|---|---|
|
Median Overall Survival (OS) - MET Exon 14 Cohort
|
24.28 months
Interval 9.2 to
The upper limit of the 90% CI is not statistically reachable.
|
SECONDARY outcome
Timeframe: Disease was evaluated at cycle 2 day 28 and at the end of every 2 cycles thereafter and in long-term survival followed-up every 3 months. Median follow-up for survival is of 24.28 months with range (0.46 months - 32.13 months).Population: The analysis population is comprised of all eligible and treated patients.
PFS based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) defined per RECIST 1.1 criteria. or death, or is censored at time of last disease assessment.
Outcome measures
| Measure |
NSCLC (Met Exon 14 Mutation)
n=12 Participants
Merestinib: Oral, predetermined dosage of 120mg per protocol, once daily per 28 day treatment cycle
|
|---|---|
|
Median Progression-free Survival (PFS) - MET Exon 14 Cohort
|
3.68 months
Interval 1.38 to
There were only 10 events, therefore the upper limit of the 90% CI is not finite.
|
SECONDARY outcome
Timeframe: Radiologic evaluation starting at cycle 2 day 28 and at the end of every 2 cycles of treatment thereafter. The median of treatment duration is 1.20 months with range (0.26 months - 28.81 months).Population: This analysis dataset is comprised of all patients who had a CR or PR on treatment.
DOR, estimated using the Kaplan Meier method, is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) per RECISTv1.1, until the first date that recurrent or progressive disease is objectively documented. Patients without PD are censored at the date of last disease assessment.
Outcome measures
| Measure |
NSCLC (Met Exon 14 Mutation)
n=1 Participants
Merestinib: Oral, predetermined dosage of 120mg per protocol, once daily per 28 day treatment cycle
|
|---|---|
|
Median Duration of Response (DOR) - MET Exon 14 Cohort
|
NA months
Only one patient had a CR/PR on treatment. This study lacks meaningful results and privacy, so the results are unreported.
|
SECONDARY outcome
Timeframe: AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of treatment duration is 1.20 months with range (0.26 months - 28.81 months).Population: This analysis dataset is comprised of all eligible and treated patients.
All grade 4-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 that are not resolved in accordance with treatment guidelines were counted. Rate is the proportion of treated participants experiencing at least one of these adverse events as defined during the time of observation.
Outcome measures
| Measure |
NSCLC (Met Exon 14 Mutation)
n=12 Participants
Merestinib: Oral, predetermined dosage of 120mg per protocol, once daily per 28 day treatment cycle
|
|---|---|
|
Grade 4-5 Treatment-related Toxicity Rate
|
0.083 proportion of paticipants
Interval 0.002 to 0.46
|
Adverse Events
NSCLC (Met Exon 14 Mutation)
Serious events: 4 serious events
Other events: 12 other events
Deaths: 7 deaths
Solid Tumor (NTRK1,2,3 Rearrangement)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NSCLC (Met Exon 14 Mutation)
n=12 participants at risk
Merestinib: Oral, predetermined dosage of 120mg per protocol, once daily per 28 day treatment cycle
|
Solid Tumor (NTRK1,2,3 Rearrangement)
Merestinib: Oral, predetermined dosage of 120mg per protocol, once daily per 28 day treatment cycle
|
|---|---|---|
|
General disorders
Edema limbs
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
Aspartate aminotransferase increased
|
25.0%
3/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
Hypertension
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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 |
NSCLC (Met Exon 14 Mutation)
n=12 participants at risk
Merestinib: Oral, predetermined dosage of 120mg per protocol, once daily per 28 day treatment cycle
|
Solid Tumor (NTRK1,2,3 Rearrangement)
Merestinib: Oral, predetermined dosage of 120mg per protocol, once daily per 28 day treatment cycle
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
2/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
Atrial fibrillation
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
Cardiac disorders - Other, specify
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
|
Eye disorders
Blurred vision
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
|
Eye disorders
Eye disorders - Other, specify
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
Abdominal pain
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
|
16.7%
2/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
Dysphagia
|
16.7%
2/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
|
25.0%
3/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
Edema limbs
|
41.7%
5/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
General disorders and administration site conditions - Other, specify
|
16.7%
2/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
Non-cardiac chest pain
|
16.7%
2/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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%
3/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
Alanine aminotransferase increased
|
41.7%
5/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
Alkaline phosphatase increased
|
16.7%
2/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
Aspartate aminotransferase increased
|
33.3%
4/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
Blood bilirubin increased
|
16.7%
2/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
Investigations - Other, specify
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
Neutrophil count decreased
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
Platelet count decreased
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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%
3/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
Hypoalbuminemia
|
25.0%
3/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
Hypocalcemia
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
Back pain
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
Muscle weakness lower limb
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
Muscle weakness upper limb
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
Musculoskeletal and connective tissue disorder - Other, specify
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
Myalgia
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
Myositis
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
|
16.7%
2/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
|
16.7%
2/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
Peripheral motor neuropathy
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
Depression
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
Allergic rhinitis
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
|
16.7%
2/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
|
25.0%
3/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
Respiratory, thoracic and mediastinal disorders - Other, specify
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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 maculo-papular
|
16.7%
2/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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
Hypertension
|
8.3%
1/12 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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.
|
—
0/0 • AE evaluated on treatment on day 1 and 15 on cycle 1, and day 1 on each cycle thereafter. The median of observation time for AE is 1.20 months with range (0.26 months - 28.81 months). The median of the observation period for all-cause mortality is 24.28 months with range (0.46 months - 32.13 months).
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