Trial Outcomes & Findings for Phase 2 Study of AT13387 (Onalespib) in ALK+ ALCL, MCL, and BCL-6+ DLBCL (NCT NCT02572453)
NCT ID: NCT02572453
Last Updated: 2022-09-13
Results Overview
Objective response (OR) = Complete + Partial (CR + PR) Per International Harmonization Project for lymphoma criteria, CR is defined as the disappearance of all evidence of disease. For FDG-avid or PET positive sites of disease prior to therapy, a mass of any size is permitted if PET negative; for variably FDG avid or PET negative lesions, regression to normal size on CT is necessary. The spleen or liver must also be nonpalpable with disappearance of any nodules, and the bone marrow, if initially involved, must be cleared on repeat biopsy. PR is defined as regression of measurable disease and no new sites of disease: a \>50% decrease in the sum of the diameters of the up to 6 largest dominant masses with no increase in size of other masses. If the sites of disease were PET positive at baseline, there must be at least one previously involved site that remains PET positive.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Assessed every 2 cycles during treatment until disease progression; patients who discontinue for reasons other than progression will be evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy
Results posted on
2022-09-13
Participant Flow
Participant milestones
| Measure |
ALK+ ALCL
Relapsed ALK+ ALCL, following Brentuximab and transplant ineligible (n=10 planned)
|
Relapsed MCL
Relapsed MCL, following Ibrutinib and transplant ineligible (n=20 planned)
|
BCL6+ DLBCL
Relapsed BCL6+ DLBCL, transplant ineligible (n=20 planned)
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
4
|
20
|
|
Overall Study
COMPLETED
|
1
|
4
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2 Study of AT13387 (Onalespib) in ALK+ ALCL, MCL, and BCL-6+ DLBCL
Baseline characteristics by cohort
| Measure |
ALK+ ALCL
n=1 Participants
Patients receive 160-mg/m2 onalespib by IV over 1 hour on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Patients will continue on treatment indefinitely as long as they are responding and tolerating treatment.
|
Relapsed MCL
n=4 Participants
Patients receive 160-mg/m2 onalespib by IV over 1 hour on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Patients will continue on treatment indefinitely as long as they are responding and tolerating treatment.
|
BCL6+ DLBCL
n=20 Participants
Patients receive 160-mg/m2 onalespib by IV over 1 hour on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Patients will continue on treatment indefinitely as long as they are responding and tolerating treatment.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Age, Continuous
|
36 years
n=99 Participants
|
66 years
n=107 Participants
|
64 years
n=206 Participants
|
64 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Assessed every 2 cycles during treatment until disease progression; patients who discontinue for reasons other than progression will be evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapyObjective response (OR) = Complete + Partial (CR + PR) Per International Harmonization Project for lymphoma criteria, CR is defined as the disappearance of all evidence of disease. For FDG-avid or PET positive sites of disease prior to therapy, a mass of any size is permitted if PET negative; for variably FDG avid or PET negative lesions, regression to normal size on CT is necessary. The spleen or liver must also be nonpalpable with disappearance of any nodules, and the bone marrow, if initially involved, must be cleared on repeat biopsy. PR is defined as regression of measurable disease and no new sites of disease: a \>50% decrease in the sum of the diameters of the up to 6 largest dominant masses with no increase in size of other masses. If the sites of disease were PET positive at baseline, there must be at least one previously involved site that remains PET positive.
Outcome measures
| Measure |
ALK+ ALCL
n=1 Participants
Patients receive 160-mg/m2 onalespib by IV over 1 hour on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Patients will continue on treatment indefinitely as long as they are responding and tolerating treatment.
|
Relapsed MCL
n=4 Participants
Patients receive 160-mg/m2 onalespib by IV over 1 hour on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Patients will continue on treatment indefinitely as long as they are responding and tolerating treatment.
|
BCL6+ DLBCL
n=20 Participants
Patients receive 160-mg/m2 onalespib by IV over 1 hour on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Patients will continue on treatment indefinitely as long as they are responding and tolerating treatment.
|
|---|---|---|---|
|
Objective Response Rate
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapyPopulation: All patients who received any amount of study treatment
Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (version 5.0 is used staring April 1, 2018). Toxicities will be summarized with counts and proportions within each cohort and overall.
Outcome measures
| Measure |
ALK+ ALCL
n=1 Participants
Patients receive 160-mg/m2 onalespib by IV over 1 hour on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Patients will continue on treatment indefinitely as long as they are responding and tolerating treatment.
|
Relapsed MCL
n=4 Participants
Patients receive 160-mg/m2 onalespib by IV over 1 hour on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Patients will continue on treatment indefinitely as long as they are responding and tolerating treatment.
|
BCL6+ DLBCL
n=20 Participants
Patients receive 160-mg/m2 onalespib by IV over 1 hour on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Patients will continue on treatment indefinitely as long as they are responding and tolerating treatment.
|
|---|---|---|---|
|
Frequency of Toxicities
Grade 3 (highest)
|
0 Participants
|
0 Participants
|
7 Participants
|
|
Frequency of Toxicities
Any grade
|
1 Participants
|
4 Participants
|
19 Participants
|
|
Frequency of Toxicities
Grade 1 (highest)
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Toxicities
Grade 2 (highest)
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Frequency of Toxicities
Grade 4 (highest)
|
0 Participants
|
1 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: From the date of study entry until documentation of first progression or death from any cause; progression assessed every 2 cycles during treatment until disease progression or deathThe progression-free survival will be estimated by Kaplan-Meier method. Progressive disease is defined by the International Harmonization Project for lymphoma criteria: any new lesion or an increase by \> 50% of previously involved sites from nadir. This includes the appearance of any new lesion(s) \> 1.5cm in any axis, a \> 50% increase in the sum of diameters of \> 1 site of disease or \> 50% increase in the longest diameter of a previously identified node \>1cm in short axis. If the sites of disease were PET positive at baseline, they must remain PET positive.
Outcome measures
| Measure |
ALK+ ALCL
n=1 Participants
Patients receive 160-mg/m2 onalespib by IV over 1 hour on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Patients will continue on treatment indefinitely as long as they are responding and tolerating treatment.
|
Relapsed MCL
n=4 Participants
Patients receive 160-mg/m2 onalespib by IV over 1 hour on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Patients will continue on treatment indefinitely as long as they are responding and tolerating treatment.
|
BCL6+ DLBCL
n=20 Participants
Patients receive 160-mg/m2 onalespib by IV over 1 hour on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Patients will continue on treatment indefinitely as long as they are responding and tolerating treatment.
|
|---|---|---|---|
|
Progression-free Survival
|
1.8 months
Interval 1.8 to 1.8
|
2.0 months
Interval 1.2 to 3.1
|
1.8 months
Interval 0.4 to 8.8
|
SECONDARY outcome
Timeframe: From the date of study entry until death from any cause; assessed every 6 months for up to 1 year after ending treatmentThe overall survival will be estimated by Kaplan-Meier method. Median follow-up time will be assessed using the reverse Kaplan-Meier method.
Outcome measures
| Measure |
ALK+ ALCL
n=1 Participants
Patients receive 160-mg/m2 onalespib by IV over 1 hour on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Patients will continue on treatment indefinitely as long as they are responding and tolerating treatment.
|
Relapsed MCL
n=4 Participants
Patients receive 160-mg/m2 onalespib by IV over 1 hour on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Patients will continue on treatment indefinitely as long as they are responding and tolerating treatment.
|
BCL6+ DLBCL
n=20 Participants
Patients receive 160-mg/m2 onalespib by IV over 1 hour on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Patients will continue on treatment indefinitely as long as they are responding and tolerating treatment.
|
|---|---|---|---|
|
Overall Survival
|
1.6 months
Interval 1.6 to 1.6
|
7.5 months
Interval 1.1 to 7.5
|
2.9 months
Interval 0.6 to 8.8
|
SECONDARY outcome
Timeframe: From first objective response (partial response or complete response) until the first date of documented progression assessed every 2 cycles or death due to any cause; assessed every 6 months up to 1 year after ending treatmentPopulation: Patients who achieved partial or complete response, n=2 of 25
Duration of response will be evaluated only in patients who respond with either a partial response or complete response while on study.
Outcome measures
| Measure |
ALK+ ALCL
Patients receive 160-mg/m2 onalespib by IV over 1 hour on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Patients will continue on treatment indefinitely as long as they are responding and tolerating treatment.
|
Relapsed MCL
Patients receive 160-mg/m2 onalespib by IV over 1 hour on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Patients will continue on treatment indefinitely as long as they are responding and tolerating treatment.
|
BCL6+ DLBCL
n=2 Participants
Patients receive 160-mg/m2 onalespib by IV over 1 hour on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Patients will continue on treatment indefinitely as long as they are responding and tolerating treatment.
|
|---|---|---|---|
|
Duration of Response
|
—
|
—
|
6.1 months
Interval 0.03 to 6.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed days 1, 8, 15 of each 28-day cycle and at treatment completion visitWill be assessed via immunohistochemistry. Comparisons will be made between baseline, on treatment, and time of progression protein levels and changes will be characterized as differences and as differences at the referenced time point as a proportion of baseline levels. An H-score will be used. The Wilcoxon rank sum test will be used to compare changes between responders and non-responders and a one-sided significance level will be used.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed days 1, 8, 15 of each 28-day cycle and at treatment completion visitWill be assessed via immunohistochemistry. Comparisons will be made between baseline, on treatment, and time of progression protein levels and changes will be characterized as differences and as differences at the referenced time point as a proportion of baseline levels. An H-score will be used. The Wilcoxon rank sum test will be used to compare changes between responders and non-responders and a one-sided significance level will be used.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed days 1, 8, 15 of each 28-day cycle and at treatment completion visitWill be assessed via immunohistochemistry. Comparisons will be made between baseline, on treatment, and time of progression protein levels. An H-score will be used. Results at each time point and as changes as a proportion of baseline levels will be reported descriptively.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed days 1, 8, 15 of each 28-day cycle and at treatment completion visitWill be measured by changes in protein levels via immunoblotting. Will use a one-sided significance level.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed days 1, 8, 15 of each 28-day cycle and at treatment completion visitWill be assessed via exome sequencing and ribonucleic acid sequencing. Absolute algorithm will be used to determine the cancer cell fraction.
Outcome measures
Outcome data not reported
Adverse Events
ALK+ ALCL
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Relapsed MCL
Serious events: 0 serious events
Other events: 4 other events
Deaths: 1 deaths
BCL6+ DLBCL
Serious events: 5 serious events
Other events: 19 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
ALK+ ALCL
n=1 participants at risk
Patients receive 160-mg/m2 onalespib by IV over 1 hour on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Patients will continue on treatment indefinitely as long as they are responding and tolerating treatment.
|
Relapsed MCL
n=4 participants at risk
Patients receive 160-mg/m2 onalespib by IV over 1 hour on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Patients will continue on treatment indefinitely as long as they are responding and tolerating treatment.
|
BCL6+ DLBCL
n=20 participants at risk
Patients receive 160-mg/m2 onalespib by IV over 1 hour on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Patients will continue on treatment indefinitely as long as they are responding and tolerating treatment.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
10.0%
2/20 • Number of events 2 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Investigations
Neutropenia
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
10.0%
2/20 • Number of events 3 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Investigations
Thrombocytopenia
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Investigations
White blood cell decreased
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Infections and infestations
Sepsis
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
General disorders
Pain
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 2 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Infections and infestations
Lung infection
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
General disorders
Fever
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
Other adverse events
| Measure |
ALK+ ALCL
n=1 participants at risk
Patients receive 160-mg/m2 onalespib by IV over 1 hour on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Patients will continue on treatment indefinitely as long as they are responding and tolerating treatment.
|
Relapsed MCL
n=4 participants at risk
Patients receive 160-mg/m2 onalespib by IV over 1 hour on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Patients will continue on treatment indefinitely as long as they are responding and tolerating treatment.
|
BCL6+ DLBCL
n=20 participants at risk
Patients receive 160-mg/m2 onalespib by IV over 1 hour on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Patients will continue on treatment indefinitely as long as they are responding and tolerating treatment.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
1/1 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
75.0%
3/4 • Number of events 16 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
65.0%
13/20 • Number of events 36 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
100.0%
4/4 • Number of events 8 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
60.0%
12/20 • Number of events 28 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
75.0%
3/4 • Number of events 4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
40.0%
8/20 • Number of events 19 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
25.0%
1/4 • Number of events 3 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
45.0%
9/20 • Number of events 27 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
25.0%
1/4 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
40.0%
8/20 • Number of events 18 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Investigations
White blood cell decreased
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
50.0%
2/4 • Number of events 2 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
35.0%
7/20 • Number of events 21 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
25.0%
1/4 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
30.0%
6/20 • Number of events 13 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
25.0%
1/4 • Number of events 2 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
30.0%
6/20 • Number of events 14 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
25.0%
1/4 • Number of events 3 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
25.0%
5/20 • Number of events 6 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Eye disorders
Blurred vision
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
50.0%
2/4 • Number of events 2 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
20.0%
4/20 • Number of events 6 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
25.0%
1/4 • Number of events 2 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
20.0%
4/20 • Number of events 14 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
50.0%
2/4 • Number of events 8 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
15.0%
3/20 • Number of events 6 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
25.0%
5/20 • Number of events 5 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
75.0%
3/4 • Number of events 4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 3 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
25.0%
1/4 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
20.0%
4/20 • Number of events 13 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
25.0%
1/4 • Number of events 6 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
15.0%
3/20 • Number of events 11 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
50.0%
2/4 • Number of events 2 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
25.0%
1/4 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
10.0%
2/20 • Number of events 4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Blood and lymphatic system disorders
Anorexia
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
10.0%
2/20 • Number of events 4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
General disorders
Chills
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
25.0%
1/4 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
10.0%
2/20 • Number of events 4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
25.0%
1/4 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 5 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
10.0%
2/20 • Number of events 7 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
10.0%
2/20 • Number of events 4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Eye disorders
Flashing lights
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
10.0%
2/20 • Number of events 7 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
25.0%
1/4 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 2 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
10.0%
2/20 • Number of events 3 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
10.0%
2/20 • Number of events 3 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
10.0%
2/20 • Number of events 3 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
10.0%
2/20 • Number of events 4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
100.0%
1/1 • Number of events 2 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Investigations
Weight loss
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
10.0%
2/20 • Number of events 3 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Gastrointestinal disorders
Belching
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
25.0%
1/4 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/20 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
25.0%
1/4 • Number of events 3 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/20 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Eye disorders
Dry eye
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
25.0%
1/4 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/20 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
100.0%
1/1 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
General disorders
Facial pain
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 3 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 2 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
25.0%
1/4 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/20 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
General disorders
Malaise
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 3 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Skin and subcutaneous tissue disorders
Sore on tongue
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Eye disorders
Visual changes
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Psychiatric disorders
Weird dreams
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/1 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
0.00%
0/4 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
5.0%
1/20 • Number of events 2 • Assessed days 1, 2, 8, 9, 15, 16 of each 28-day cycle during treatment until progression; patients who discontinue for reasons other than progression evaluated every 6 months for up to 1 year after ending treatment or until progression or next therapy. Patients who discontinue due to unacceptable toxicity will be followed until resolution
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting up until March 31, 2018. Starting April 1, 2018, CTCAE version 5.0 will be utilized for AE reporting. CTCAE version 5.0 became available prior to April 1, 2018.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60