Trial Outcomes & Findings for A Study Using Regorafenib as Second or Third Line Therapy in Metastatic Medullary Thyroid Cancer (NCT NCT02657551)
NCT ID: NCT02657551
Last Updated: 2026-08-12
Results Overview
10-month PFS Rate is the proportion of participants ramaing alive and progression free at 10 months. Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.1 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
10 months
Results posted on
2026-08-12
Participant Flow
Enrollment period: 04/21/2016-02/27/2019
Participant milestones
| Measure |
Medullary Thyroid Carcinoma (MTC)
Regorafenib dose is dependent on observed significant drug related toxicities (SDRT) over cycle 1. SDRT is defined as any grade 2 or higher toxicity. For cycle 1, participants receive 80mg (2\*40mg tablets) for one week. If no SDRTs, then dose is escalated to 120mg (3 tablets) for week two. Again, if no SDRTs, then dose is escalated to 160mg (4 tablets) for week three. For cycle 2-onwards, each participant received the highest tolerated dose on cycle 1. Each cycle is one daily dose for 3 weeks and 1 week off. No actual dose-escalation occurred within cycle 1 despite this potential per protocol; all participants received 80mg.
|
Differentiated Thyroid Cancer (DTC)
Regorafenib dose is dependent on observed significant drug related toxicities (SDRT) over cycle 1. SDRT is defined as any grade 2 or higher toxicity. For cycle 1, participants receive 80mg (2\*40mg tablets) for one week. If no SDRTs, then dose is escalated to 120mg (3 tablets) for week two. Again, if no SDRTs, then dose is escalated to 160mg (4 tablets) for week three. For cycle 2-onwards, each participant received the highest tolerated dose on cycle 1. Each cycle is one daily dose for 3 weeks and 1 week off. No actual dose-escalation occurred within cycle 1 despite this potential per protocol; all participants received 80mg.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
Reasons for withdrawal
| Measure |
Medullary Thyroid Carcinoma (MTC)
Regorafenib dose is dependent on observed significant drug related toxicities (SDRT) over cycle 1. SDRT is defined as any grade 2 or higher toxicity. For cycle 1, participants receive 80mg (2\*40mg tablets) for one week. If no SDRTs, then dose is escalated to 120mg (3 tablets) for week two. Again, if no SDRTs, then dose is escalated to 160mg (4 tablets) for week three. For cycle 2-onwards, each participant received the highest tolerated dose on cycle 1. Each cycle is one daily dose for 3 weeks and 1 week off. No actual dose-escalation occurred within cycle 1 despite this potential per protocol; all participants received 80mg.
|
Differentiated Thyroid Cancer (DTC)
Regorafenib dose is dependent on observed significant drug related toxicities (SDRT) over cycle 1. SDRT is defined as any grade 2 or higher toxicity. For cycle 1, participants receive 80mg (2\*40mg tablets) for one week. If no SDRTs, then dose is escalated to 120mg (3 tablets) for week two. Again, if no SDRTs, then dose is escalated to 160mg (4 tablets) for week three. For cycle 2-onwards, each participant received the highest tolerated dose on cycle 1. Each cycle is one daily dose for 3 weeks and 1 week off. No actual dose-escalation occurred within cycle 1 despite this potential per protocol; all participants received 80mg.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Non-Compliance
|
1
|
0
|
|
Overall Study
Progression / Relapse
|
4
|
2
|
|
Overall Study
Physician Decision
|
0
|
3
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
A Study Using Regorafenib as Second or Third Line Therapy in Metastatic Medullary Thyroid Cancer
Baseline characteristics by cohort
| Measure |
Medullary Thyroid Carcinoma (MTC)
n=8 Participants
Regorafenib dose is dependent on observed significant drug related toxicities (SDRT) over cycle 1. SDRT is defined as any grade 2 or higher toxicity. For cycle 1, participants receive 80mg (2\*40mg tablets) for one week. If no SDRTs, then dose is escalated to 120mg (3 tablets) for week two. Again, if no SDRTs, then dose is escalated to 160mg (4 tablets) for week three. For cycle 2-onwards, each participant received the highest tolerated dose on cycle 1. Each cycle is one daily dose for 3 weeks and 1 week off. No actual dose-escalation occurred within cycle 1 despite this potential per protocol; all participants received 80mg.
|
Differentiated Thyroid Cancer (DTC)
n=9 Participants
Regorafenib dose is dependent on observed significant drug related toxicities (SDRT) over cycle 1. SDRT is defined as any grade 2 or higher toxicity. For cycle 1, participants receive 80mg (2\*40mg tablets) for one week. If no SDRTs, then dose is escalated to 120mg (3 tablets) for week two. Again, if no SDRTs, then dose is escalated to 160mg (4 tablets) for week three. For cycle 2-onwards, each participant received the highest tolerated dose on cycle 1. Each cycle is one daily dose for 3 weeks and 1 week off. No actual dose-escalation occurred within cycle 1 despite this potential per protocol; all participants received 80mg.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.2 years
STANDARD_DEVIATION 4.62 • n=1 Participants
|
61.5 years
STANDARD_DEVIATION 11.9 • n=1 Participants
|
58.1 years
STANDARD_DEVIATION 9.73 • n=1 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=1 Participants
|
5 Participants
n=1 Participants
|
7 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=1 Participants
|
4 Participants
n=1 Participants
|
10 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=1 Participants
|
8 Participants
n=1 Participants
|
13 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=1 Participants
|
8 Participants
n=1 Participants
|
12 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Black of African American
|
0 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
|
Smoking History
Yes
|
4 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
7 Participants
n=1 Participants
|
|
Smoking History
No
|
4 Participants
n=1 Participants
|
6 Participants
n=1 Participants
|
10 Participants
n=1 Participants
|
|
ECOG Performance Status
0
|
4 Participants
n=1 Participants
|
2 Participants
n=1 Participants
|
6 Participants
n=1 Participants
|
|
ECOG Performance Status
1
|
4 Participants
n=1 Participants
|
7 Participants
n=1 Participants
|
11 Participants
n=1 Participants
|
PRIMARY outcome
Timeframe: 10 months10-month PFS Rate is the proportion of participants ramaing alive and progression free at 10 months. Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.1 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
Outcome measures
| Measure |
MTC Cohort
n=8 Participants
Regorafenib dose is dependent on observed significant drug related toxicities (SDRT) over cycle 1. SDRT is defined as any grade 2 or higher toxicity. For cycle 1, participants receive 80mg (2\*40mg tablets) for one week. If no SDRTs, then dose is escalated to 120mg (3 tablets) for week two. Again, if no SDRTs, then dose is escalated to 160mg (4 tablets) for week three. For cycle 2-onwards, each participant received the highest tolerated dose on cycle 1. Each cycle is one daily dose for 3 weeks and 1 week off. No actual dose-escalation occurred within cycle 1 despite this potential per protocol; all participants received 80mg.
|
Differentiated Thyroid Cancer (DTC)
Regorafenib dose is dependent on observed significant drug related toxicities (SDRT) over cycle 1. SDRT is defined as any grade 2 or higher toxicity. For cycle 1, participants receive 80mg (2\*40mg tablets) for one week. If no SDRTs, then dose is escalated to 120mg (3 tablets) for week two. Again, if no SDRTs, then dose is escalated to 160mg (4 tablets) for week three. For cycle 2-onwards, each participant received the highest tolerated dose on cycle 1. Each cycle is one daily dose for 3 weeks and 1 week off. No actual dose-escalation occurred within cycle 1 despite this potential per protocol; all participants received 80mg.
|
|---|---|---|
|
10-month Progression-free Survival (PFS) Rate [MTC Cohort]
|
0.125 proportion of participants
Interval 0.003 to 0.527
|
—
|
PRIMARY outcome
Timeframe: Up to 23.9 months. Tumor assessments were performed at baseline, on Day 1 of Cycle 3, and every 28 days thereafter. After treatment discontinuation, assessments continued every 2 months (±7 days).ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Outcome measures
| Measure |
MTC Cohort
n=9 Participants
Regorafenib dose is dependent on observed significant drug related toxicities (SDRT) over cycle 1. SDRT is defined as any grade 2 or higher toxicity. For cycle 1, participants receive 80mg (2\*40mg tablets) for one week. If no SDRTs, then dose is escalated to 120mg (3 tablets) for week two. Again, if no SDRTs, then dose is escalated to 160mg (4 tablets) for week three. For cycle 2-onwards, each participant received the highest tolerated dose on cycle 1. Each cycle is one daily dose for 3 weeks and 1 week off. No actual dose-escalation occurred within cycle 1 despite this potential per protocol; all participants received 80mg.
|
Differentiated Thyroid Cancer (DTC)
Regorafenib dose is dependent on observed significant drug related toxicities (SDRT) over cycle 1. SDRT is defined as any grade 2 or higher toxicity. For cycle 1, participants receive 80mg (2\*40mg tablets) for one week. If no SDRTs, then dose is escalated to 120mg (3 tablets) for week two. Again, if no SDRTs, then dose is escalated to 160mg (4 tablets) for week three. For cycle 2-onwards, each participant received the highest tolerated dose on cycle 1. Each cycle is one daily dose for 3 weeks and 1 week off. No actual dose-escalation occurred within cycle 1 despite this potential per protocol; all participants received 80mg.
|
|---|---|---|
|
Objective Response Rate (ORR) [DTC Cohort]
|
11.1 percentage of participants
Interval 0.3 to 48.3
|
—
|
SECONDARY outcome
Timeframe: AEs were evaluated on treatment cycle 1 day 1 of week 1, 2 and 3, and cycle 2 day 1 of week 1 and 3, and cycle 3 and beyond day 1 of week 1. For this study cohort, participants were evaluated for AEs for the maximum treatment duration up to 24 months.Grade 3-5 toxicity rate is defined as the proportion of participants who experienced at least one grade 3-5 adverse event (AE) of any type during the time of observation. All AEs were summarized and graded based on CTCAE v4.
Outcome measures
| Measure |
MTC Cohort
n=8 Participants
Regorafenib dose is dependent on observed significant drug related toxicities (SDRT) over cycle 1. SDRT is defined as any grade 2 or higher toxicity. For cycle 1, participants receive 80mg (2\*40mg tablets) for one week. If no SDRTs, then dose is escalated to 120mg (3 tablets) for week two. Again, if no SDRTs, then dose is escalated to 160mg (4 tablets) for week three. For cycle 2-onwards, each participant received the highest tolerated dose on cycle 1. Each cycle is one daily dose for 3 weeks and 1 week off. No actual dose-escalation occurred within cycle 1 despite this potential per protocol; all participants received 80mg.
|
Differentiated Thyroid Cancer (DTC)
n=9 Participants
Regorafenib dose is dependent on observed significant drug related toxicities (SDRT) over cycle 1. SDRT is defined as any grade 2 or higher toxicity. For cycle 1, participants receive 80mg (2\*40mg tablets) for one week. If no SDRTs, then dose is escalated to 120mg (3 tablets) for week two. Again, if no SDRTs, then dose is escalated to 160mg (4 tablets) for week three. For cycle 2-onwards, each participant received the highest tolerated dose on cycle 1. Each cycle is one daily dose for 3 weeks and 1 week off. No actual dose-escalation occurred within cycle 1 despite this potential per protocol; all participants received 80mg.
|
|---|---|---|
|
Grade 3-5 Toxicity Rate
|
0.63 proportion of participant
Interval 0.25 to 0.91
|
0.67 proportion of participant
Interval 0.3 to 0.93
|
SECONDARY outcome
Timeframe: Assessed at Cycle 1 Day 1 and end of treatment. The maximum treatment duration was 23.9 months.Population: The number analyzed reflects the number of participants who completed the question at both cycle 1 day 1 and end of treatment.
The MDASI-Thy assesses the severity of symptoms, including 13 core symptom items, 6 additional module symptom items, and 6 interference items, at their worst in the past 24 hours using a 0-10 numerical rating scale, where higher scores indicate worse symptoms. For each section (core symptoms, thyroid-specific symptoms, and interference), the section score is calculated as the mean of the item scores and therefore ranges from 0 to 10. Change scores were calculated as the end-of-treatment section score minus the corresponding Cycle 1 Day 1 section score.
Outcome measures
| Measure |
MTC Cohort
n=7 Participants
Regorafenib dose is dependent on observed significant drug related toxicities (SDRT) over cycle 1. SDRT is defined as any grade 2 or higher toxicity. For cycle 1, participants receive 80mg (2\*40mg tablets) for one week. If no SDRTs, then dose is escalated to 120mg (3 tablets) for week two. Again, if no SDRTs, then dose is escalated to 160mg (4 tablets) for week three. For cycle 2-onwards, each participant received the highest tolerated dose on cycle 1. Each cycle is one daily dose for 3 weeks and 1 week off. No actual dose-escalation occurred within cycle 1 despite this potential per protocol; all participants received 80mg.
|
Differentiated Thyroid Cancer (DTC)
n=5 Participants
Regorafenib dose is dependent on observed significant drug related toxicities (SDRT) over cycle 1. SDRT is defined as any grade 2 or higher toxicity. For cycle 1, participants receive 80mg (2\*40mg tablets) for one week. If no SDRTs, then dose is escalated to 120mg (3 tablets) for week two. Again, if no SDRTs, then dose is escalated to 160mg (4 tablets) for week three. For cycle 2-onwards, each participant received the highest tolerated dose on cycle 1. Each cycle is one daily dose for 3 weeks and 1 week off. No actual dose-escalation occurred within cycle 1 despite this potential per protocol; all participants received 80mg.
|
|---|---|---|
|
Change From Cycle 1 Day 1 in MD Anderson Symptom Inventory-Thyroid (MDASI-Thy) Score
core symptom severity
|
0.1 score on a scale
Interval -1.0 to 2.2
|
0.8 score on a scale
Interval 0.5 to 1.0
|
|
Change From Cycle 1 Day 1 in MD Anderson Symptom Inventory-Thyroid (MDASI-Thy) Score
module symptom severity
|
0.3 score on a scale
Interval -1.8 to 1.5
|
1.5 score on a scale
Interval 1.0 to 2.7
|
|
Change From Cycle 1 Day 1 in MD Anderson Symptom Inventory-Thyroid (MDASI-Thy) Score
interference
|
0.6 score on a scale
Interval -0.3 to 2.5
|
1.1 score on a scale
Interval -1.0 to 3.5
|
Adverse Events
Medullary Thyroid Carcinoma (MTC)
Serious events: 8 serious events
Other events: 0 other events
Deaths: 4 deaths
Differentiated Thyroid Cancer (DTC)
Serious events: 9 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Medullary Thyroid Carcinoma (MTC)
n=8 participants at risk
Regorafenib dose is dependent on observed significant drug related toxicities (SDRT) over cycle 1. SDRT is defined as any grade 2 or higher toxicity. For cycle 1, participants receive 80mg (2\*40mg tablets) for one week. If no SDRTs, then dose is escalated to 120mg (3 tablets) for week two. Again, if no SDRTs, then dose is escalated to 160mg (4 tablets) for week three. For cycle 2-onwards, each participant received the highest tolerated dose on cycle 1. Each cycle is one daily dose for 3 weeks and 1 week off. No actual dose-escalation occurred within cycle 1 despite this potential per protocol; all participants received 80mg.
|
Differentiated Thyroid Cancer (DTC)
n=9 participants at risk
Regorafenib dose is dependent on observed significant drug related toxicities (SDRT) over cycle 1. SDRT is defined as any grade 2 or higher toxicity. For cycle 1, participants receive 80mg (2\*40mg tablets) for one week. If no SDRTs, then dose is escalated to 120mg (3 tablets) for week two. Again, if no SDRTs, then dose is escalated to 160mg (4 tablets) for week three. For cycle 2-onwards, each participant received the highest tolerated dose on cycle 1. Each cycle is one daily dose for 3 weeks and 1 week off. No actual dose-escalation occurred within cycle 1 despite this potential per protocol; all participants received 80mg.
|
|---|---|---|
|
Endocrine disorders
Hypoparathyroidism
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Endocrine disorders
Hypothyroidism
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
66.7%
6/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Eye disorders
Blurred vision
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Eye disorders
Dry eye
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Eye disorders
Eye pain
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Abdominal pain
|
37.5%
3/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Cheilitis
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
2/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
22.2%
2/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
22.2%
2/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
22.2%
2/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Diarrhea
|
87.5%
7/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
66.7%
6/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
33.3%
3/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
44.4%
4/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Gastritis
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
33.3%
3/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Mucositis oral
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
66.7%
6/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
22.2%
2/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Oral pain
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
33.3%
3/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
44.4%
4/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
22.2%
2/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
General disorders
Chills
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
General disorders
Edema face
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
General disorders
Facial pain
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
General disorders
Fatigue
|
87.5%
7/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
77.8%
7/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
General disorders
Fever
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
22.2%
2/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
General disorders
Gait disturbance
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
General disorders
Neck edema
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
General disorders
Non-cardiac chest pain
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
33.3%
3/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
General disorders
Pain
|
50.0%
4/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
22.2%
2/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Infections and infestations
Lymph gland infection
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Infections and infestations
Skin infection
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
22.2%
2/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
33.3%
3/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Investigations
Alkaline phosphatase increased
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
44.4%
4/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Investigations
Aspartate aminotransferase increased
|
37.5%
3/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
44.4%
4/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Investigations
Blood bilirubin increased
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Investigations
Cholesterol high
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
33.3%
3/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Investigations
Creatinine increased
|
25.0%
2/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Investigations
GGT increased
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Investigations
Lymphocyte count decreased
|
25.0%
2/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Investigations
Platelet count decreased
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
22.2%
2/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Investigations
Weight loss
|
50.0%
4/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Investigations
White blood cell decreased
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Investigations
Investigations - Other, specify
|
25.0%
2/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
22.2%
2/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Metabolism and nutrition disorders
Anorexia
|
37.5%
3/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
22.2%
2/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
22.2%
2/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
50.0%
4/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
50.0%
4/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
33.3%
3/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
2/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
22.2%
2/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
22.2%
2/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
22.2%
2/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
25.0%
2/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
44.4%
4/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
44.4%
4/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
44.4%
4/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Nervous system disorders
Paresthesia
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
2/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Psychiatric disorders
Anxiety
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
44.4%
4/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Psychiatric disorders
Depression
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
33.3%
3/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
22.2%
2/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Renal and urinary disorders
Proteinuria
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
22.2%
2/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
55.6%
5/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
2/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
55.6%
5/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
37.5%
3/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
44.4%
4/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
25.0%
2/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
22.2%
2/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
33.3%
3/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
2/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
75.0%
6/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
55.6%
5/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
25.0%
2/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
22.2%
2/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
62.5%
5/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
33.3%
3/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Vascular disorders
Hot flashes
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Vascular disorders
Hypertension
|
25.0%
2/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
77.8%
7/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
11.1%
1/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
12.5%
1/8 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/9 • AEs were evaluated on Cycle 1 Day 1 of Weeks 1, 2, and 3; Cycle 2 Day 1 of Weeks 1 and 3; and Day 1 of Week 1 for Cycle 3 and beyond. Participants were followed for AEs and survival status for up to 24.9 months.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place