Trial Outcomes & Findings for Vorinostat With XRT and 5-FU for Locally Advanced Adenocarcinoma of the Pancreas (NCT NCT00948688)
NCT ID: NCT00948688
Last Updated: 2017-05-10
Results Overview
The maximum tolerated dose (MTD) is defined as one dose level below the dose level at which participants experience an unacceptable rate of dose-limiting toxicity.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
6 weeks
Results posted on
2017-05-10
Participant Flow
Participant milestones
| Measure |
Vorinostat 200 mg
Vorinostat 200 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
|
Vorinostat 100 mg
Vorinostat 100 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
|
|---|---|---|
|
Period 1: 200 mg Vorinostat
STARTED
|
4
|
0
|
|
Period 1: 200 mg Vorinostat
COMPLETED
|
2
|
0
|
|
Period 1: 200 mg Vorinostat
NOT COMPLETED
|
2
|
0
|
|
Period 2: 100 mg Vorinostat
STARTED
|
0
|
6
|
|
Period 2: 100 mg Vorinostat
COMPLETED
|
0
|
5
|
|
Period 2: 100 mg Vorinostat
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Vorinostat 200 mg
Vorinostat 200 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
|
Vorinostat 100 mg
Vorinostat 100 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
|
|---|---|---|
|
Period 1: 200 mg Vorinostat
Adverse Event
|
1
|
0
|
|
Period 1: 200 mg Vorinostat
Protocol Violation
|
1
|
0
|
|
Period 2: 100 mg Vorinostat
Adverse Event
|
0
|
1
|
Baseline Characteristics
Vorinostat With XRT and 5-FU for Locally Advanced Adenocarcinoma of the Pancreas
Baseline characteristics by cohort
| Measure |
Vorinostat, 5-FU, Radiation Therapy
n=10 Participants
Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
Radiation therapy: Once per day, 5 days a week for 6 weeks
5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy
Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
60.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksThe maximum tolerated dose (MTD) is defined as one dose level below the dose level at which participants experience an unacceptable rate of dose-limiting toxicity.
Outcome measures
| Measure |
Vorinostat, 5-FU, Radiation Therapy
n=10 Participants
Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
Radiation therapy: Once per day, 5 days a week for 6 weeks
5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy
Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug
|
Vorinostat 100 mg
Vorinostat 100 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
|
|---|---|---|
|
Maximally Tolerated Dose (MTD) of Vorinostat in Combination With Infusional 5-FU and Radiation Therapy.
|
NA milligrams per day
Criteria for Maximum Tolerated Dose (MTD) were not met before premature closure of the study and therefore a MTD was not determined.
|
—
|
PRIMARY outcome
Timeframe: 7 monthsProgression free survival was defined as the duration of time from registration on study to time of objective disease progression. Death was regarded as a progression event. Progression was defined by the Response Evaluation Criteria in Solid Tumors (RECIST) as at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions as seen on radiologic evaluation.
Outcome measures
| Measure |
Vorinostat, 5-FU, Radiation Therapy
n=10 Participants
Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
Radiation therapy: Once per day, 5 days a week for 6 weeks
5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy
Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug
|
Vorinostat 100 mg
Vorinostat 100 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
|
|---|---|---|
|
Progression Free Survival (PFS) at 7 Months From Registration
|
NA months
Interval 1.74342 to
The estimated survival probability never reached 50% during 7 months of follow-up, so the median and 95% CI could not be calculated.
|
—
|
SECONDARY outcome
Timeframe: 2 yearsProgression free survival for this endpoint was defined as the duration of time from beginning of the patients' initial chemotherapy to time of objective disease progression. Death was regarded as a progression event. Progression was defined by the Response Evaluation Criteria in Solid Tumors (RECIST) as at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions as seen on radiologic evaluation.
Outcome measures
| Measure |
Vorinostat, 5-FU, Radiation Therapy
n=10 Participants
Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
Radiation therapy: Once per day, 5 days a week for 6 weeks
5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy
Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug
|
Vorinostat 100 mg
Vorinostat 100 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
|
|---|---|---|
|
Progression Free Survival
|
9.375 months
Interval 1.7434 to 13.7829
|
—
|
SECONDARY outcome
Timeframe: 1 yearAll participants who receive at least one dose of study treatment were evaluable for toxicity. Unacceptable toxicity is based on the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Most grade 3 (severe) or 4 (life-threatening) events are considered to be unacceptable toxicities -- exceptions include nausea or vomiting, fatigue, and alopecia. Hematologic toxicities need to be either grade 4 or last for protocol-defined durations to be considered unacceptable.
Outcome measures
| Measure |
Vorinostat, 5-FU, Radiation Therapy
n=4 Participants
Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
Radiation therapy: Once per day, 5 days a week for 6 weeks
5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy
Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug
|
Vorinostat 100 mg
n=6 Participants
Vorinostat 100 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
|
|---|---|---|
|
Number of Participants Experiencing Unacceptable Toxicity
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: One participant excluded from this analysis due to non-compliance with study drug administration.
Percentage of participants still alive at 1 year after enrollment on study
Outcome measures
| Measure |
Vorinostat, 5-FU, Radiation Therapy
n=9 Participants
Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
Radiation therapy: Once per day, 5 days a week for 6 weeks
5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy
Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug
|
Vorinostat 100 mg
Vorinostat 100 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
|
|---|---|---|
|
Overall Survival
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: One participant excluded from this analysis due to non-compliance with study drug administration.
Participants who have either a complete response (disappearance of all target lesions), partial response (at least 30% decrease in sum of longest diameter of target lesions) or stable disease (decrease in size of less than 30% or increase in size of less than 20%).
Outcome measures
| Measure |
Vorinostat, 5-FU, Radiation Therapy
n=9 Participants
Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
Radiation therapy: Once per day, 5 days a week for 6 weeks
5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy
Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug
|
Vorinostat 100 mg
Vorinostat 100 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
|
|---|---|---|
|
Response Rate
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: 5 monthsPopulation: One participant excluded from this analysis due to non-compliance with study drug administration.
Percentage of patients able to undergo surgical resection after protocol therapy.
Outcome measures
| Measure |
Vorinostat, 5-FU, Radiation Therapy
n=9 Participants
Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
Radiation therapy: Once per day, 5 days a week for 6 weeks
5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy
Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug
|
Vorinostat 100 mg
Vorinostat 100 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
|
|---|---|---|
|
Resectability Rate
|
2 Participants
|
—
|
Adverse Events
Vorinostat 200mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Vorinostat 100mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vorinostat 200mg
n=4 participants at risk
Vorinostat 200 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)during each week of radiation therapy
|
Vorinostat 100mg
n=6 participants at risk
Vorinostat 100 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease Progression NOS
|
0.00%
0/4 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Gastrointestinal disorders
Dehydration
|
25.0%
1/4 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
0.00%
0/6 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
Other adverse events
| Measure |
Vorinostat 200mg
n=4 participants at risk
Vorinostat 200 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)during each week of radiation therapy
|
Vorinostat 100mg
n=6 participants at risk
Vorinostat 100 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
|
|---|---|---|
|
Investigations
Hemoglobin
|
25.0%
1/4 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
50.0%
3/6 • Number of events 3 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Investigations
Leukocytes
|
75.0%
3/4 • Number of events 3 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
33.3%
2/6 • Number of events 2 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Investigations
Lymphopenia
|
75.0%
3/4 • Number of events 3 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
100.0%
6/6 • Number of events 6 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Investigations
Neutrophils
|
25.0%
1/4 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
0.00%
0/6 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Investigations
Platelets
|
25.0%
1/4 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
66.7%
4/6 • Number of events 4 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Cardiac disorders
Arrhythmia-other
|
25.0%
1/4 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
0.00%
0/6 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
General disorders
Fatigue
|
100.0%
4/4 • Number of events 4 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
100.0%
6/6 • Number of events 6 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
General disorders
Fever w/o neutropenia
|
0.00%
0/4 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
General disorders
Rigors/chills
|
25.0%
1/4 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Investigations
Weight gain
|
0.00%
0/4 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Investigations
Weight loss
|
75.0%
3/4 • Number of events 3 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/4 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.0%
1/4 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
0.00%
0/6 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
0.00%
0/4 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
50.0%
2/4 • Number of events 2 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 2 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
100.0%
4/4 • Number of events 4 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
0.00%
0/6 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
0.00%
0/4 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Metabolism and nutrition disorders
Anorexia
|
75.0%
3/4 • Number of events 3 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
33.3%
2/6 • Number of events 2 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
33.3%
2/6 • Number of events 2 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
75.0%
3/4 • Number of events 3 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
33.3%
2/6 • Number of events 2 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Gastrointestinal disorders
Dysphagia
|
25.0%
1/4 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
0.00%
0/6 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
50.0%
2/4 • Number of events 2 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
50.0%
2/4 • Number of events 2 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
4/4 • Number of events 4 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
66.7%
4/6 • Number of events 4 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Hepatobiliary disorders
Stenosis (incl anastomotic) biliary tree
|
0.00%
0/4 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Gastrointestinal disorders
Taste disturbance
|
0.00%
0/4 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
25.0%
1/4 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
0.00%
0/6 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Infections and infestations
Infection Gr0-2 neut, upper airway
|
25.0%
1/4 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
General disorders
Edema limb
|
50.0%
2/4 • Number of events 2 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
0.00%
0/6 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Blood and lymphatic system disorders
Lymphatics-other
|
0.00%
0/4 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 2 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
2/4 • Number of events 2 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
33.3%
2/6 • Number of events 2 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Investigations
Alkaline phosphatase
|
25.0%
1/4 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Investigations
ALT, SGPT
|
0.00%
0/4 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
33.3%
2/6 • Number of events 2 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Investigations
AST, SGOT
|
25.0%
1/4 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
50.0%
3/6 • Number of events 3 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Investigations
Bicarbonate
|
25.0%
1/4 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Investigations
Bilirubin
|
0.00%
0/4 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
1/4 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
0.00%
0/6 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Metabolism and nutrition disorders
Creatinine
|
0.00%
0/4 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
2/4 • Number of events 2 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
66.7%
4/6 • Number of events 4 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/4 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/4 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
33.3%
2/6 • Number of events 2 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
2/4 • Number of events 2 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
2/4 • Number of events 2 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Nervous system disorders
Dizziness
|
50.0%
2/4 • Number of events 2 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
33.3%
2/6 • Number of events 2 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Nervous system disorders
Neuropathy-sensory
|
0.00%
0/4 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Gastrointestinal disorders
Abdomen, pain
|
0.00%
0/4 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
50.0%
3/6 • Number of events 3 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
25.0%
1/4 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
33.3%
2/6 • Number of events 2 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
0.00%
0/4 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
General disorders
Pain-other
|
0.00%
0/4 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
0.00%
0/6 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
1/4 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
16.7%
1/6 • Number of events 1 • Approximately 3 months. Any events experienced while on study medication, throughout the study, and within 30 days of the last dose of study medication.
Information on all adverse events, whether reported by the participant, directly observed, or detected by physical examination, laboratory test or other means, will be collected, recorded, followed and reported.
|
Additional Information
Lawrence S. Blaszkowsky, M.D.
Massachusetts General Hospital
Phone: 617-219-1230
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place