Trial Outcomes & Findings for Ruxolitinib for Cancer Cachexia (NCT NCT04906746)
NCT ID: NCT04906746
Last Updated: 2026-07-07
Results Overview
To assess toxicity with use of Ruxolitinib in NSCLC (non-small cell lung cancer) cachexia patients, NCI's CTCAE v5.0 toxicity criteria will be used to measure Ruxolitinib-related side effects. Grade 3 or higher events will be recorded.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
EARLY_PHASE1
Target enrollment
10 participants
Primary outcome timeframe
3 months
Results posted on
2026-07-07
Participant Flow
Participant milestones
| Measure |
Received Ruxolitinib
Intra-patient dose-escalated ruxolitinib: 0 MG po bid for 1 month (Month 1), 10 MG po bid for 1 month (Month 2), 15 MG po bid for 1 month (Month 3).
All dose levels are combined into a single arm assessing effects of ruxolitinib as outlined in the study protocol.
|
|---|---|
|
Month 1: 0mg Ruxolitinib
STARTED
|
10
|
|
Month 1: 0mg Ruxolitinib
COMPLETED
|
6
|
|
Month 1: 0mg Ruxolitinib
NOT COMPLETED
|
4
|
|
Month 2: 10mg Ruxolitinib
STARTED
|
6
|
|
Month 2: 10mg Ruxolitinib
COMPLETED
|
2
|
|
Month 2: 10mg Ruxolitinib
NOT COMPLETED
|
4
|
|
Month 3: 15mg Ruxolitinib
STARTED
|
2
|
|
Month 3: 15mg Ruxolitinib
COMPLETED
|
2
|
|
Month 3: 15mg Ruxolitinib
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Received Ruxolitinib
Intra-patient dose-escalated ruxolitinib: 0 MG po bid for 1 month (Month 1), 10 MG po bid for 1 month (Month 2), 15 MG po bid for 1 month (Month 3).
All dose levels are combined into a single arm assessing effects of ruxolitinib as outlined in the study protocol.
|
|---|---|
|
Month 2: 10mg Ruxolitinib
Physician Decision
|
4
|
Baseline Characteristics
Ruxolitinib for Cancer Cachexia
Baseline characteristics by cohort
| Measure |
Dosing Regimen for Ruxolitinib
n=10 Participants
Level 0: Ruxolitinib 0 MG po bid for 1 month (Month 1)
Level 1: Ruxolitinib 10 MG po bid for 1 month (Month 2)
Level 2: Ruxolitinib 15 MG po bid for 1 month (Month 3)
Identify any dose-limiting toxicity (DLT) when ruxolitinib is administered to NSCLC cachexia patients.: There will be intra-patient dose escalation of ruxolitinib in every patient enrolled on study.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=20 Participants
|
|
Age, Continuous
|
78 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=20 Participants
|
|
Histopathology
Squamous Non-small-cell Lung cancer
|
4 Participants
n=20 Participants
|
|
Histopathology
Non-squamous Non-small-cell Lung cancer
|
6 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 2 Participants received at least one dose of 10 mg BID Ruxolitinib and proceeded to receive at least one dose of 15 mg BID Ruxolitinib. All patients enrolled were included in the Ruxolitinib 0mg group, which was not assessed for outcomes because of its baseline status, and is not included in this table.
To assess toxicity with use of Ruxolitinib in NSCLC (non-small cell lung cancer) cachexia patients, NCI's CTCAE v5.0 toxicity criteria will be used to measure Ruxolitinib-related side effects. Grade 3 or higher events will be recorded.
Outcome measures
| Measure |
15mg Ruxolitinib
n=2 Participants
Intra-patient dose-escalated ruxolitinib: 0 MG po bid for 1 month (Month 1), 10 MG po bid for 1 month (Month 2), 15 MG po bid for 1 month (Month 3).
|
10mg Ruxolitinib
n=2 Participants
Intra-patient dose-escalated ruxolitinib: 0 MG po bid for 1 month (Month 1), 10 MG po bid for 1 month (Month 2), 15 MG po bid for 1 month (Month 3).
|
|---|---|---|
|
Number of Non-small Cell Lung Cancer Cachexia Patients With Toxicity With the Use of Ruxolitinib
Participants with Grade 3 or higher SAE possibly, probably, or definitely related to Ruxolitinib
|
0 Participants
|
0 Participants
|
|
Number of Non-small Cell Lung Cancer Cachexia Patients With Toxicity With the Use of Ruxolitinib
Participants with Grade 3 or higher SAE unrelated to Ruxolitinib
|
0 Participants
|
0 Participants
|
|
Number of Non-small Cell Lung Cancer Cachexia Patients With Toxicity With the Use of Ruxolitinib
Participants with no SAE
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 2 Participants received at least one dose of 10 mg BID Ruxolitinib and proceeded to receive at least one dose of 15 mg BID Ruxolitinib. All patients enrolled were included in the Ruxolitinib 0mg group, which was not assessed for outcomes because of its baseline status, and is not included in this table.
To assess toxicity with use of Ruxolitinib in NSCLC (non-small cell lung cancer) cachexia patients, NCI's CTCAE v5.0 toxicity criteria will be used to measure Ruxolitinib-related side effects. Grade 3 or higher events will be recorded.
Outcome measures
| Measure |
15mg Ruxolitinib
Intra-patient dose-escalated ruxolitinib: 0 MG po bid for 1 month (Month 1), 10 MG po bid for 1 month (Month 2), 15 MG po bid for 1 month (Month 3).
|
10mg Ruxolitinib
n=2 Participants
Intra-patient dose-escalated ruxolitinib: 0 MG po bid for 1 month (Month 1), 10 MG po bid for 1 month (Month 2), 15 MG po bid for 1 month (Month 3).
|
|---|---|---|
|
Number of Non-small Cell Lung Cancer Cachexia Patients With Toxicity With the Use of Ruxolitinib
10mg Ruxolitinib Group
|
—
|
0 Participants
|
|
Number of Non-small Cell Lung Cancer Cachexia Patients With Toxicity With the Use of Ruxolitinib
15mg Ruxolitinib Group
|
—
|
0 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: 2 participants agreed to DEXA scans and completed both the 10mg and 15mg Ruxolitinib arms. All patients enrolled were included in the Ruxolitinib 0mg group, which was not assessed for outcomes because of its baseline status, and is not included in this table.
Body weight will be measured every 2 weeks while on study, including 1 month of follow-up. Both DEXA (dual-energy x-ray absorptiometry) imaging every 2 weeks while on study/follow-up and CT-based imaging with auto-segmentation will provide measures of how Ruxolitinib may be suppressing cachexia-associated adipose and muscle loss.
Outcome measures
| Measure |
15mg Ruxolitinib
n=2 Participants
Intra-patient dose-escalated ruxolitinib: 0 MG po bid for 1 month (Month 1), 10 MG po bid for 1 month (Month 2), 15 MG po bid for 1 month (Month 3).
|
10mg Ruxolitinib
n=2 Participants
Intra-patient dose-escalated ruxolitinib: 0 MG po bid for 1 month (Month 1), 10 MG po bid for 1 month (Month 2), 15 MG po bid for 1 month (Month 3).
|
|---|---|---|
|
Analysis of Any Preliminary Evidence Suggesting That Ruxolitinib Suppresses Adipose and Lean Muscle Loss in Cancer Cachexia Patients
Protection of fat and lean mass observed
|
2 Participants
|
2 Participants
|
|
Analysis of Any Preliminary Evidence Suggesting That Ruxolitinib Suppresses Adipose and Lean Muscle Loss in Cancer Cachexia Patients
No protection of fat and lean mass observed
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: 2 participants received at least one dose of 10 mg Ruxolitinib and proceeded to receive at least one dose of 15 mg Ruxolitinib. All patients enrolled were included in the Ruxolitinib 0mg group, which was not assessed for outcomes because of its baseline status, and is not included in this table.
Anorexia will be assessed with the EORTC QLQ-CAX24 questionnaire as well as direct clinical history taking every 2 weeks on study. Descriptive statistics will be used to report changes.
Outcome measures
| Measure |
15mg Ruxolitinib
n=2 Participants
Intra-patient dose-escalated ruxolitinib: 0 MG po bid for 1 month (Month 1), 10 MG po bid for 1 month (Month 2), 15 MG po bid for 1 month (Month 3).
|
10mg Ruxolitinib
n=2 Participants
Intra-patient dose-escalated ruxolitinib: 0 MG po bid for 1 month (Month 1), 10 MG po bid for 1 month (Month 2), 15 MG po bid for 1 month (Month 3).
|
|---|---|---|
|
Analysis of Any Preliminary Evidence Suggesting That Ruxolitinib Suppresses Anorexia in Cancer Cachexia Patients.
EORTC QLQ-CAX24 score improved while on treatment
|
0 Participants
|
0 Participants
|
|
Analysis of Any Preliminary Evidence Suggesting That Ruxolitinib Suppresses Anorexia in Cancer Cachexia Patients.
EORTC QLQ-CAX24 score did not improve while on treatment
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 2 Participants received at least one dose of 10 mg BID Ruxolitinib and proceeded to receive at least one dose of 15 mg BID Ruxolitinib. All patients enrolled were included in the Ruxolitinib 0mg group, which was not assessed for outcomes because of its baseline status, and is not included in this table.
For the secondary objective of overall adverse event assessment, the investigator will again use NCI's CTCAE v5.0 toxicity criteria throughout the trial evaluation. All events, regardless of grade, will be recorded.
Outcome measures
| Measure |
15mg Ruxolitinib
n=2 Participants
Intra-patient dose-escalated ruxolitinib: 0 MG po bid for 1 month (Month 1), 10 MG po bid for 1 month (Month 2), 15 MG po bid for 1 month (Month 3).
|
10mg Ruxolitinib
n=2 Participants
Intra-patient dose-escalated ruxolitinib: 0 MG po bid for 1 month (Month 1), 10 MG po bid for 1 month (Month 2), 15 MG po bid for 1 month (Month 3).
|
|---|---|---|
|
Number of Adverse Events Associated With Ruxolitinib When Administered to Cancer Cachexia Patients
|
3 Adverse events related to Ruxolitinib
|
3 Adverse events related to Ruxolitinib
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 2 Participants received at least one dose of 10 mg BID Ruxolitinib and proceeded to receive at least one dose of 15 mg BID Ruxolitinib. All patients enrolled were included in the Ruxolitinib 0mg group, which was not assessed for outcomes because of its baseline status, and is not included in this table.
Patient tumor response will be determined by CT-based imaging (CT, PET/CT), MRI (brain evaluation), and other clinical indicators (bronchoscopy, image-guided biopsies), etc. with RECIST and/or iRECIST criteria response criteria as a function of Ruxolitinib use and dose. In patients with measurable disease, preliminary evidence of Ruxolitinib's anti-tumor activity by assessment of objective response as determined by RECIST in cancer cachexia patients will be used. Two such measurements will be conducted during the course of the trial. iRECIST criteria will be utilized as needed for unconfirmed cases of progression when applicable.
Outcome measures
| Measure |
15mg Ruxolitinib
n=2 Participants
Intra-patient dose-escalated ruxolitinib: 0 MG po bid for 1 month (Month 1), 10 MG po bid for 1 month (Month 2), 15 MG po bid for 1 month (Month 3).
|
10mg Ruxolitinib
n=2 Participants
Intra-patient dose-escalated ruxolitinib: 0 MG po bid for 1 month (Month 1), 10 MG po bid for 1 month (Month 2), 15 MG po bid for 1 month (Month 3).
|
|---|---|---|
|
Number of Participants With Objective Response (OR) as Determined by RECIST Criteria
Stable disease
|
1 Participants
|
1 Participants
|
|
Number of Participants With Objective Response (OR) as Determined by RECIST Criteria
Partial response
|
1 Participants
|
1 Participants
|
|
Number of Participants With Objective Response (OR) as Determined by RECIST Criteria
Disease progression
|
0 Participants
|
0 Participants
|
|
Number of Participants With Objective Response (OR) as Determined by RECIST Criteria
Unknown
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: 2 Participants received at least one dose of 10 mg BID Ruxolitinib and proceeded to receive at least one dose of 15 mg BID Ruxolitinib. All patients enrolled were included in the Ruxolitinib 0mg group, which was not assessed for outcomes because of its baseline status, and is not included in this table.
Quality of life questionnaires while on ruxolitinib will be assessed with the EORTC QLQ-CAX24 (The European Organization for Research and Treatment of Cancer quality of life questionnaire). Questionnaire was given to patients every 2 weeks for 3 months while on study treatment and at 1 month follow-up.
Outcome measures
| Measure |
15mg Ruxolitinib
n=2 Participants
Intra-patient dose-escalated ruxolitinib: 0 MG po bid for 1 month (Month 1), 10 MG po bid for 1 month (Month 2), 15 MG po bid for 1 month (Month 3).
|
10mg Ruxolitinib
n=2 Participants
Intra-patient dose-escalated ruxolitinib: 0 MG po bid for 1 month (Month 1), 10 MG po bid for 1 month (Month 2), 15 MG po bid for 1 month (Month 3).
|
|---|---|---|
|
Analysis Providing Any Preliminary Evidence That Ruxolitinib Improves Quality of Life (QoL) for Cancer Cachexia Patients
No improvement in quality of life questionnaires
|
2 Participants
|
2 Participants
|
|
Analysis Providing Any Preliminary Evidence That Ruxolitinib Improves Quality of Life (QoL) for Cancer Cachexia Patients
Improvement in quality of life questionnaires
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: 2 Participants received at least one dose of 10 mg BID Ruxolitinib and proceeded to receive at least one dose of 15 mg BID Ruxolitinib. All patients enrolled were included in the Ruxolitinib 0mg group, which was not assessed for outcomes because of its baseline status, and is not included in this table.
To describe any preliminary evidence suggesting that Ruxolitinib suppresses body weight loss in cancer cachexia patients. Body weight will be measured every 2 weeks while on study, including 1 month of follow-up, to provide measures of how Ruxolitinib may be suppressing cachexia-associated body weight loss.
Outcome measures
| Measure |
15mg Ruxolitinib
n=2 Participants
Intra-patient dose-escalated ruxolitinib: 0 MG po bid for 1 month (Month 1), 10 MG po bid for 1 month (Month 2), 15 MG po bid for 1 month (Month 3).
|
10mg Ruxolitinib
n=2 Participants
Intra-patient dose-escalated ruxolitinib: 0 MG po bid for 1 month (Month 1), 10 MG po bid for 1 month (Month 2), 15 MG po bid for 1 month (Month 3).
|
|---|---|---|
|
Suppression of Body Weight Loss in Cancer Cachexia Patients
Maintenance or increase in weight
|
1 Participants
|
2 Participants
|
|
Suppression of Body Weight Loss in Cancer Cachexia Patients
Decrease in weight
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 2 Participants received at least one dose of 10 mg BID Ruxolitinib and proceeded to receive at least one dose of 15 mg BID Ruxolitinib. All patients enrolled were included in the Ruxolitinib 0mg group, which was not assessed for outcomes because of its baseline status, and is not included in this table.
Overall survival (OS) will be assessed for all patients while on and off Ruxolitinib. There will be one determination of OS at 6 months from start of active phase of study. Estimates will be descriptively presented using the Kaplan-Meier method.
Outcome measures
| Measure |
15mg Ruxolitinib
n=2 Participants
Intra-patient dose-escalated ruxolitinib: 0 MG po bid for 1 month (Month 1), 10 MG po bid for 1 month (Month 2), 15 MG po bid for 1 month (Month 3).
|
10mg Ruxolitinib
Intra-patient dose-escalated ruxolitinib: 0 MG po bid for 1 month (Month 1), 10 MG po bid for 1 month (Month 2), 15 MG po bid for 1 month (Month 3).
|
|---|---|---|
|
Analysis of Any Preliminary Evidence Suggesting That Ruxolitinib Improves Overall Survival in Cancer Cachexia Patients.
Alive
|
2 Participants
|
—
|
|
Analysis of Any Preliminary Evidence Suggesting That Ruxolitinib Improves Overall Survival in Cancer Cachexia Patients.
Deceased
|
0 Participants
|
—
|
Adverse Events
Ruxolitinib 0mg
Serious events: 2 serious events
Other events: 8 other events
Deaths: 2 deaths
Ruxolitinib 10mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Ruxolitinib 15mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ruxolitinib 0mg
n=8 participants at risk
Intra-patient dose-escalated ruxolitinib: 0 MG po bid for 1 month (Month 1), 10 MG po bid for 1 month (Month 2), 15 MG po bid for 1 month (Month 3).
This arm is for patients that received 0mg ruxolitinib on month 1 of the study.
|
Ruxolitinib 10mg
n=2 participants at risk
Intra-patient dose-escalated ruxolitinib: 0 MG po bid for 1 month (Month 1), 10 MG po bid for 1 month (Month 2), 15 MG po bid for 1 month (Month 3).
This arm is for patients that received 10mg ruxolitinib on month 2 of treatment.
|
Ruxolitinib 15mg
n=2 participants at risk
Intra-patient dose-escalated ruxolitinib: 0 MG po bid for 1 month (Month 1), 10 MG po bid for 1 month (Month 2), 15 MG po bid for 1 month (Month 3).
This arm is for patients that received 15mg ruxolitinib on month 3 of treatment.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
General disorders
Death NOS
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Gastrointestinal disorders
Gastric perforation
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
General disorders
Disease progression
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
Other adverse events
| Measure |
Ruxolitinib 0mg
n=8 participants at risk
Intra-patient dose-escalated ruxolitinib: 0 MG po bid for 1 month (Month 1), 10 MG po bid for 1 month (Month 2), 15 MG po bid for 1 month (Month 3).
This arm is for patients that received 0mg ruxolitinib on month 1 of the study.
|
Ruxolitinib 10mg
n=2 participants at risk
Intra-patient dose-escalated ruxolitinib: 0 MG po bid for 1 month (Month 1), 10 MG po bid for 1 month (Month 2), 15 MG po bid for 1 month (Month 3).
This arm is for patients that received 10mg ruxolitinib on month 2 of treatment.
|
Ruxolitinib 15mg
n=2 participants at risk
Intra-patient dose-escalated ruxolitinib: 0 MG po bid for 1 month (Month 1), 10 MG po bid for 1 month (Month 2), 15 MG po bid for 1 month (Month 3).
This arm is for patients that received 15mg ruxolitinib on month 3 of treatment.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Blood and lymphatic system disorders
Anemia
|
37.5%
3/8 • Number of events 5 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/8 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Investigations
Creatinine increased
|
0.00%
0/8 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
2/8 • Number of events 2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
General disorders
Edema limbs
|
0.00%
0/8 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Investigations
Investigations - Other, RBC decreased
|
37.5%
3/8 • Number of events 3 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
25.0%
2/8 • Number of events 2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
2/8 • Number of events 2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Nervous system disorders
Dysgeusia
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Skin and subcutaneous tissue disorders
Rash pustular
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Eye disorders
Eye pain
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Eye disorders
Eye disorders - Other, specify: Eye discharge
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Eye disorders
Dry eye
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
25.0%
2/8 • Number of events 2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Renal and urinary disorders
Urinary frequency
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
General disorders
Fatigue
|
25.0%
2/8 • Number of events 2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Investigations
Investigations - Other, specify: Low hematocrit
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Investigations
Lymphocyte count decreased
|
37.5%
3/8 • Number of events 7 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Investigations
Investigations - Other, specify: Monocyte count decreased
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Investigations
Investigations, Other - specify: Blood urea nitrogen increased
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Psychiatric disorders
Hallucinations
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Investigations
White blood cell decreased
|
12.5%
1/8 • Number of events 2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Investigations
Platelet count decreased
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
2/8 • Number of events 2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Investigations
Neutrophil count decreased
|
12.5%
1/8 • Number of events 2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Infections and infestations
Sepsis
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
General disorders
Chills
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Psychiatric disorders
Delirium
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Nervous system disorders
Lethargy
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Gastrointestinal disorders
Mucositis oral
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
General disorders
Fever
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Psychiatric disorders
Anxiety
|
25.0%
2/8 • Number of events 2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
|
Infections and infestations
Hepatitis viral
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
0.00%
0/2 • Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.
Adverse events were assessed for up to 6 months after the start of the treatment phase. Due to physician-discretion and lab-mediated dose reductions, 4 patients halted treatment, with ongoing adverse events reported in the 0mg arm.
|
Additional Information
Dr. Tu Dan
University of Texas Southwestern Medical Center
Phone: 2146458525
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place