Trial Outcomes & Findings for A Study Comparing Niraparib Versus Platinum-Taxane Doublet Chemotherapy as Neoadjuvant Treatment in Participants With Homologous Recombination-Deficient Stage III/IV Ovarian Cancer (COHORT-C) (NCT NCT06964165)
NCT ID: NCT06964165
Last Updated: 2025-11-26
Results Overview
Pre-IDS unconfirmed ORR is defined as the percentage of participants with unconfirmed complete or partial response on study treatment pre-IDS as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by the Investigator. Complete Response (CR) is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Up to approximately 102 weeks
Results posted on
2025-11-26
Participant Flow
This study is a sub study of the master protocol (NCT03574779).
Participant milestones
| Measure |
Platinum-taxane
Participants with ovarian cancer received platinum-taxane doublet chemotherapy as solution for intravenous infusion for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent interval debulking surgery (IDS) with recovery period of up to 6 weeks. After IDS, all participants received another three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional followed by niraparib maintenance treatment for up to 36 months or until an adverse event (AE), progression of disease (PD) per RECIST v1.1.
|
Niraparib
Participants with ovarian cancer received 100 milligram (mg) Niraparib capsules orally for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent IDS with recovery period of up to 6 weeks. After IDS, all participants received three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional, followed by niraparib maintenance treatment for up to 36 months or until an AE, PD per RECIST v1.1. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelets count ≥ 150000 cells per microliter were administered 300 mg of Niraparib. Participants with screening actual body weight less than 77 kg or screening platelets count less than 150000 cells per microliter were administered 200 mg of niraparib.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
19
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
17
|
19
|
Reasons for withdrawal
| Measure |
Platinum-taxane
Participants with ovarian cancer received platinum-taxane doublet chemotherapy as solution for intravenous infusion for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent interval debulking surgery (IDS) with recovery period of up to 6 weeks. After IDS, all participants received another three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional followed by niraparib maintenance treatment for up to 36 months or until an adverse event (AE), progression of disease (PD) per RECIST v1.1.
|
Niraparib
Participants with ovarian cancer received 100 milligram (mg) Niraparib capsules orally for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent IDS with recovery period of up to 6 weeks. After IDS, all participants received three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional, followed by niraparib maintenance treatment for up to 36 months or until an AE, PD per RECIST v1.1. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelets count ≥ 150000 cells per microliter were administered 300 mg of Niraparib. Participants with screening actual body weight less than 77 kg or screening platelets count less than 150000 cells per microliter were administered 200 mg of niraparib.
|
|---|---|---|
|
Overall Study
Death
|
4
|
4
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Study terminated by sponsor
|
12
|
10
|
|
Overall Study
Participant discontinued due to relocation to a long-term care facility
|
0
|
1
|
|
Overall Study
Participant removed due to non-compliance
|
0
|
1
|
Baseline Characteristics
A Study Comparing Niraparib Versus Platinum-Taxane Doublet Chemotherapy as Neoadjuvant Treatment in Participants With Homologous Recombination-Deficient Stage III/IV Ovarian Cancer (COHORT-C)
Baseline characteristics by cohort
| Measure |
Platinum-taxane
n=17 Participants
Participants with ovarian cancer received platinum-taxane doublet chemotherapy as solution for intravenous infusion for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent interval debulking surgery (IDS) with recovery period of up to 6 weeks. After IDS, all participants received another three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional followed by niraparib maintenance treatment for up to 36 months or until an adverse event (AE), progression of disease (PD) per RECIST v1.1.
|
Niraparib
n=19 Participants
Participants with ovarian cancer received 100 milligram (mg) Niraparib capsules orally for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent IDS with recovery period of up to 6 weeks. After IDS, all participants received three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional, followed by niraparib maintenance treatment for up to 36 months or until an AE, PD per RECIST v1.1. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelets count ≥ 150000 cells per microliter were administered 300 mg of Niraparib. Participants with screening actual body weight less than 77 kg or screening platelets count less than 150000 cells per microliter were administered 200 mg of niraparib.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.0 YEARS
STANDARD_DEVIATION 13.67 • n=492 Participants
|
58.4 YEARS
STANDARD_DEVIATION 12.26 • n=492 Participants
|
59.6 YEARS
STANDARD_DEVIATION 12.82 • n=984 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=492 Participants
|
19 Participants
n=492 Participants
|
36 Participants
n=984 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=492 Participants
|
3 Participants
n=492 Participants
|
4 Participants
n=984 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
16 Participants
n=492 Participants
|
16 Participants
n=492 Participants
|
32 Participants
n=984 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 102 weeksPopulation: Intent-to-Treat population included all randomized participants whether or not randomized treatment was administered.
Pre-IDS unconfirmed ORR is defined as the percentage of participants with unconfirmed complete or partial response on study treatment pre-IDS as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by the Investigator. Complete Response (CR) is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters
Outcome measures
| Measure |
Platinum-taxane
n=17 Participants
Participants with ovarian cancer received platinum-taxane doublet chemotherapy as solution for intravenous infusion for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent interval debulking surgery (IDS) with recovery period of up to 6 weeks. After IDS, all participants received another three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional followed by niraparib maintenance treatment for up to 36 months or until an adverse event (AE), progression of disease (PD) per RECIST v1.1.
|
Niraparib
n=19 Participants
Participants with ovarian cancer received 100 milligram (mg) Niraparib capsules orally for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent IDS with recovery period of up to 6 weeks. After IDS, all participants received three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional, followed by niraparib maintenance treatment for up to 36 months or until an AE, PD per RECIST v1.1. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelets count ≥ 150000 cells per microliter were administered 300 mg of Niraparib. Participants with screening actual body weight less than 77 kg or screening platelets count less than 150000 cells per microliter were administered 200 mg of niraparib.
|
|---|---|---|
|
Pre-Interval Debulking Surgery (IDS) Unconfirmed Overall Response Rate (ORR)
|
70.6 Percentage of Participants
Interval 44.04 to 89.69
|
31.6 Percentage of Participants
Interval 16.34 to 67.71
|
SECONDARY outcome
Timeframe: At week 24Population: Intent-to-Treat population
Serum samples were collected to assess CA-125 progression based on the GCIG CA-125 response criteria, which is defined as follows: Criteria 1 - For participants with elevated CA-125 levels pre-treatment that reduced to the normal range during the study, progression is defined as CA-125 ≥2× Upper limit of normal (ULN) on 2 occasions at least 1 week apart.; Criteria 2 - For participants with elevated CA-125 levels pre-treatment that did not reduce to the normal range during the study, progression is defined as CA-125 ≥2× the nadir value on 2 occasions at least 1 week apart.; Criteria 3 - For participants with CA-125 levels in the normal range pre-treatment, progression is defined as CA-125 ≥2× ULN on 2 occasions at least 1 week apart.
Outcome measures
| Measure |
Platinum-taxane
n=17 Participants
Participants with ovarian cancer received platinum-taxane doublet chemotherapy as solution for intravenous infusion for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent interval debulking surgery (IDS) with recovery period of up to 6 weeks. After IDS, all participants received another three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional followed by niraparib maintenance treatment for up to 36 months or until an adverse event (AE), progression of disease (PD) per RECIST v1.1.
|
Niraparib
n=19 Participants
Participants with ovarian cancer received 100 milligram (mg) Niraparib capsules orally for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent IDS with recovery period of up to 6 weeks. After IDS, all participants received three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional, followed by niraparib maintenance treatment for up to 36 months or until an AE, PD per RECIST v1.1. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelets count ≥ 150000 cells per microliter were administered 300 mg of Niraparib. Participants with screening actual body weight less than 77 kg or screening platelets count less than 150000 cells per microliter were administered 200 mg of niraparib.
|
|---|---|---|
|
Number of Participants With Cancer Antigen (CA)-125 Progression by Gynecological Cancer InterGroup (GCIG) CA-125 Response Criteria
Criteria 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Cancer Antigen (CA)-125 Progression by Gynecological Cancer InterGroup (GCIG) CA-125 Response Criteria
Criteria 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Cancer Antigen (CA)-125 Progression by Gynecological Cancer InterGroup (GCIG) CA-125 Response Criteria
Criteria 3
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 154 weeksPopulation: As pre-specified in Section 2 of the Statistical Analysis Plan, analyses was not performed due to low maturity (\<30%) for PFS data, resulting from insufficient number of participants with events within the length of follow-up in assessing the number of events.
PFS is defined as the time from the date of treatment randomization to the date of first documentation of disease progression (PD) per RECIST v1.1 or death by any cause, whichever occurs first, as determined by the Investigator. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 154 weeksPopulation: As pre-specified in Section 2 of the Statistical Analysis Plan, analyses was not performed due to low maturity (\<30%) for OS data, resulting from insufficient number of participants with events within the length of follow-up in assessing the number of events.
OS is defined as the time from the date of treatment randomization to the date of death by any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 154 weeksPopulation: As pre-specified in Section 2 of the Statistical Analysis Plan, analyses was not performed due to low maturity (\<30%) for TFST data, resulting from insufficient number of participants with events within the length of follow-up in assessing the number of events.
TFST is defined as the time from the date of treatment randomization to the date of first subsequent anticancer therapy or death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Predose), Day 8 and 15 of Cycle 1; Day 1, 8 and 15 of Cycle 2 and Cycle 3; Pre-IDS Evaluation, and End of Treatment (Up to approximately 154 weeks).Population: Intent to Treat Population is included as the Overall Number of Participants Analyzed. 'Number Analyzed' refers to participants evaluable at the specified time points. The "0" participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups.
The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants of cancer clinical studies. It characterizes the frequency and severity of adverse events using a standardized scoring system. Responses include 0 ("never" OR "none" OR "Not at all"); 1 ("Rarely" OR "Mild" OR "A little bit"); 2 ("Occasionally" OR "Moderate" OR "Somewhat"); 3 ("Frequently" OR "Severe" OR "Quite a bit") and 4 ("almost constantly" OR "very severe" OR "Very much"), with a higher score indicating a higher frequency and severity of adverse events.
Outcome measures
| Measure |
Platinum-taxane
n=17 Participants
Participants with ovarian cancer received platinum-taxane doublet chemotherapy as solution for intravenous infusion for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent interval debulking surgery (IDS) with recovery period of up to 6 weeks. After IDS, all participants received another three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional followed by niraparib maintenance treatment for up to 36 months or until an adverse event (AE), progression of disease (PD) per RECIST v1.1.
|
Niraparib
n=19 Participants
Participants with ovarian cancer received 100 milligram (mg) Niraparib capsules orally for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent IDS with recovery period of up to 6 weeks. After IDS, all participants received three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional, followed by niraparib maintenance treatment for up to 36 months or until an AE, PD per RECIST v1.1. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelets count ≥ 150000 cells per microliter were administered 300 mg of Niraparib. Participants with screening actual body weight less than 77 kg or screening platelets count less than 150000 cells per microliter were administered 200 mg of niraparib.
|
|---|---|---|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, End Of Treatment, Severity, 4=Very severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 1 Day 15, Frequency, 1=Rarely
|
6 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 3 Day 8, Severity, 2=Moderate
|
4 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 3 Day 1, Severity, 2=Moderate
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 1 Day 8, Severity, 1=Mild
|
1 Participants
|
7 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 2 Day 1, Severity, 1=Mild
|
2 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Baseline, Severity, 0=None
|
10 Participants
|
9 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Baseline, Severity, 1=Mild
|
3 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Baseline, Severity, 2=Moderate
|
1 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Baseline, Severity, 3=Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Baseline, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 1 Day 8, Severity, 0=None
|
6 Participants
|
7 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 1 Day 8, Severity, 1=Mild
|
3 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 1 Day 8, Severity, 2=Moderate
|
2 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 1 Day 8, Severity, 3=Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 1 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 1 Day 15, Severity, 0=None
|
12 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 1 Day 15, Severity, 1=Mild
|
1 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 1 Day 15, Severity, 2=Moderate
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 1 Day 15, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 1 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 2 Day 1, Severity, 0=None
|
9 Participants
|
8 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 2 Day 1, Severity, 1=Mild
|
2 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 2 Day 1, Severity, 2=Moderate
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 2 Day 1, Severity, 3=Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 2 Day 1, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 2 Day 8, Severity, 0=None
|
6 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 2 Day 8, Severity, 1=Mild
|
3 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 2 Day 8, Severity, 2=Moderate
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 2 Day 8, Severity, 3=Severe
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 2 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 2 Day 15, Severity, 0=None
|
8 Participants
|
10 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 2 Day 15, Severity, 1=Mild
|
5 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 2 Day 15, Severity, 2=Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 2 Day 15, Severity, 3=Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 2 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 3 Day 1, Severity, 0=None
|
12 Participants
|
8 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 3 Day 1, Severity, 1=Mild
|
2 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 3 Day 1, Severity, 2=Moderate
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 3 Day 1, Severity, 3=Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 3 Day 1, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 3 Day 8, Severity, 0=None
|
1 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 3 Day 8, Severity, 1=Mild
|
3 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 3 Day 8, Severity, 2=Moderate
|
4 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 3 Day 8, Severity, 3=Severe
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 3 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 3 Day 15, Severity, 0=None
|
3 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 3 Day 15, Severity, 1=Mild
|
2 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 3 Day 15, Severity, 2=Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 3 Day 15, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Cycle 3 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Pre-IDS Evaluation, Severity, 0=None
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Pre-IDS Evaluation, Severity, 1=Mild
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Pre-IDS Evaluation, Severity, 2=Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Pre-IDS Evaluation, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, Pre-IDS Evaluation, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, End Of Treatment, Severity, 0=None
|
—
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, End Of Treatment, Severity, 1=Mild
|
—
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, End Of Treatment, Severity, 2=Moderate
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, End Of Treatment, Severity, 3=Severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs Tasting Food/Drink, End Of Treatment, Severity, 4=Very severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Baseline, Severity, 0=None
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Baseline, Severity, 1=Mild
|
5 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Baseline, Severity, 2=Moderate
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Baseline, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Baseline, Severity, 4=Very severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Baseline, Frequency, 0=Never
|
7 Participants
|
8 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Baseline, Frequency, 1=Rarely
|
6 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Baseline, Frequency, 2=Occasionally
|
1 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Baseline, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Baseline, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 1 Day 8, Severity, 0=None
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 1 Day 8, Severity, 1=Mild
|
3 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 1 Day 8, Severity, 2=Moderate
|
5 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 1 Day 8, Severity, 3=Severe
|
0 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 1 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 1 Day 8, Frequency, 0=Never
|
2 Participants
|
8 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 1 Day 8, Frequency, 1=Rarely
|
4 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 1 Day 8, Frequency, 2=Occasionally
|
4 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 1 Day 8, Frequency, 3=Frequently
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 1 Day 8, Frequency, 4=Almost constantly
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 1 Day 15, Severity, 0=None
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 1 Day 15, Severity, 1=Mild
|
3 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 1 Day 15, Severity, 2=Moderate
|
2 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 1 Day 15, Severity, 3=Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 1 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 1 Day 15, Frequency, 0=Never
|
8 Participants
|
7 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 1 Day 15, Frequency, 1=Rarely
|
3 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 1 Day 15, Frequency, 2=Occasionally
|
3 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 8, Severity, 1=Mild
|
4 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 1 Day 15, Frequency, 3=Frequently
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 1 Day 15, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 1, Severity, 0=None
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 1, Severity, 1=Mild
|
0 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 1, Severity, 2=Moderate
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 1, Severity, 3=Severe
|
0 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 1, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 1, Frequency, 0=Never
|
9 Participants
|
7 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 1, Frequency, 1=Rarely
|
2 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 1, Frequency, 2=Occasionally
|
0 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 1, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 1, Frequency, 4=Almost constantly
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 8, Severity, 0=None
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 8, Severity, 2=Moderate
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 8, Severity, 3=Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 8, Frequency, 0=Never
|
6 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 8, Frequency, 1=Rarely
|
3 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 8, Frequency, 2=Occasionally
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 8, Frequency, 3=Frequently
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 8, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 15, Severity, 0=None
|
0 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 15, Severity, 1=Mild
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 15, Severity, 2=Moderate
|
0 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 15, Severity, 3=Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 15, Frequency, 0=Never
|
11 Participants
|
8 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 15, Frequency, 1=Rarely
|
1 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 15, Frequency, 2=Occasionally
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 15, Frequency, 3=Frequently
|
0 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 1, Severity, 3=Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 2 Day 15, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 1, Severity, 0=None
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 1, Severity, 1=Mild
|
2 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 1, Severity, 2=Moderate
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 1, Severity, 4=Very severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 1, Frequency, 0=Never
|
12 Participants
|
8 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 1, Frequency, 1=Rarely
|
2 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 1, Frequency, 2=Occasionally
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 1, Frequency, 3=Frequently
|
0 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 1, Frequency, 4=Almost constantly
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 8, Severity, 0=None
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 8, Severity, 1=Mild
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 8, Severity, 2=Moderate
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 8, Severity, 3=Severe
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 8, Frequency, 0=Never
|
5 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 8, Frequency, 1=Rarely
|
2 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 8, Frequency, 2=Occasionally
|
0 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 8, Frequency, 3=Frequently
|
3 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 8, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 15, Severity, 0=None
|
0 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 15, Severity, 1=Mild
|
3 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 15, Severity, 2=Moderate
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 15, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 15, Frequency, 0=Never
|
1 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Baseline, Severity, 2=Moderate
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 15, Frequency, 1=Rarely
|
3 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 15, Frequency, 2=Occasionally
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 15, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Cycle 3 Day 15, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Pre-IDS Evaluation, Frequency, 0=Never
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Pre-IDS Evaluation, Frequency, 1=Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Pre-IDS Evaluation, Frequency, 2=Occasionally
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Pre-IDS Evaluation, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, Pre-IDS Evaluation, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, End Of Treatment, Severity, 0=None
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, End Of Treatment, Severity, 1=Mild
|
—
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, End Of Treatment, Severity, 2=Moderate
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, End Of Treatment, Severity, 3=Severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, End Of Treatment, Severity, 4=Very severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, End Of Treatment, Frequency, 0=Never
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, End Of Treatment, Frequency, 1=Rarely
|
—
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, End Of Treatment, Frequency, 2=Occasionally
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, End Of Treatment, Frequency, 3=Frequently
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea, End Of Treatment, Frequency, 4=Almost constantly
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Baseline, Severity, 0=None
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Baseline, Severity, 1=Mild
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Baseline, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Baseline, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Baseline, Frequency, 0=Never
|
13 Participants
|
16 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Baseline, Frequency, 1=Rarely
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Baseline, Frequency, 2=Occasionally
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Baseline, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Baseline, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 1 Day 8, Severity, 0=None
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 1 Day 8, Severity, 1=Mild
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 1 Day 8, Severity, 2=Moderate
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 1 Day 8, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 1 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 1 Day 8, Frequency, 0=Never
|
10 Participants
|
12 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 1, Severity, 1=Mild
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 1 Day 8, Frequency, 1=Rarely
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 1 Day 8, Frequency, 2=Occasionally
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 1 Day 8, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 1 Day 8, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 1 Day 15, Severity, 0=None
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 1 Day 15, Severity, 1=Mild
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 1 Day 15, Severity, 2=Moderate
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 1 Day 15, Severity, 3=Severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 1 Day 15, Severity, 4=Very severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 1 Day 15, Frequency, 0=Never
|
14 Participants
|
12 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 1 Day 15, Frequency, 1=Rarely
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Baseline, Severity, 0=None
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 1 Day 15, Frequency, 2=Occasionally
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 1 Day 15, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 1 Day 15, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 1, Severity, 0=None
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 1, Severity, 2=Moderate
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 1, Severity, 3=Severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 1, Severity, 4=Very severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 1, Frequency, 0=Never
|
11 Participants
|
12 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 1, Frequency, 1=Rarely
|
0 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 1, Frequency, 2=Occasionally
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 1, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 1, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 8, Severity, 0=None
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 8, Severity, 1=Mild
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 8, Severity, 2=Moderate
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 8, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 8, Frequency, 0=Never
|
10 Participants
|
9 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 8, Frequency, 1=Rarely
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 8, Frequency, 2=Occasionally
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 8, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 8, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 15, Severity, 0=None
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 15, Severity, 1=Mild
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 15, Severity, 2=Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 15, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Baseline, Severity, 1=Mild
|
5 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 15, Frequency, 0=Never
|
12 Participants
|
13 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 15, Frequency, 1=Rarely
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 15, Frequency, 2=Occasionally
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 15, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 2 Day 15, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 1, Severity, 0=None
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 1, Severity, 1=Mild
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 1, Severity, 2=Moderate
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 1, Severity, 3=Severe
|
—
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 1, Severity, 4=Very severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 1, Frequency, 0=Never
|
14 Participants
|
11 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 1, Frequency, 1=Rarely
|
0 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 1, Frequency, 2=Occasionally
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 1, Frequency, 3=Frequently
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 1, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 8, Severity, 0=None
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 8, Severity, 1=Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 8, Severity, 2=Moderate
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 8, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 8, Frequency, 0=Never
|
9 Participants
|
9 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 8, Frequency, 1=Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Baseline, Severity, 2=Moderate
|
4 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 8, Frequency, 2=Occasionally
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 8, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 8, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 15, Severity, 0=None
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 15, Severity, 1=Mild
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 15, Severity, 2=Moderate
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 15, Severity, 3=Severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 15, Severity, 4=Very severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 15, Frequency, 0=Never
|
5 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 15, Frequency, 1=Rarely
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 15, Frequency, 2=Occasionally
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 15, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Cycle 3 Day 15, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Pre-IDS Evaluation, Frequency, 0=Never
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Pre-IDS Evaluation, Frequency, 1=Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Pre-IDS Evaluation, Frequency, 2=Occasionally
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Pre-IDS Evaluation, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, Pre-IDS Evaluation, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, End Of Treatment, Severity, 0=None
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, End Of Treatment, Severity, 1=Mild
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, End Of Treatment, Severity, 2=Moderate
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, End Of Treatment, Severity, 3=Severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, End Of Treatment, Severity, 4=Very severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, End Of Treatment, Frequency, 0=Never
|
—
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, End Of Treatment, Frequency, 1=Rarely
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, End Of Treatment, Frequency, 2=Occasionally
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, End Of Treatment, Frequency, 3=Frequently
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting, End Of Treatment, Frequency, 4=Almost constantly
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Baseline, Severity, 0=None
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Baseline, Severity, 1=Mild
|
7 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Baseline, Severity, 2=Moderate
|
3 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Baseline, Severity, 3=Severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Baseline, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Baseline, Frequency, 0=Never
|
3 Participants
|
9 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Baseline, Frequency, 1=Rarely
|
5 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Baseline, Frequency, 2=Occasionally
|
3 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Baseline, Frequency, 3=Frequently
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Baseline, Frequency, 4=Almost constantly
|
2 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 1 Day 8, Severity, 0=None
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 1 Day 8, Severity, 1=Mild
|
3 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 1 Day 8, Severity, 2=Moderate
|
4 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 1 Day 8, Severity, 3=Severe
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 1 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 1 Day 8, Frequency, 0=Never
|
3 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 1 Day 8, Frequency, 1=Rarely
|
1 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 1 Day 8, Frequency, 2=Occasionally
|
5 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 1 Day 8, Frequency, 3=Frequently
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 1 Day 8, Frequency, 4=Almost constantly
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 1 Day 15, Severity, 0=None
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 1 Day 15, Severity, 1=Mild
|
5 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 1 Day 15, Severity, 2=Moderate
|
3 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 1 Day 15, Severity, 3=Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 1 Day 15, Severity, 4=Very severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 1 Day 15, Frequency, 0=Never
|
6 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 1 Day 15, Frequency, 1=Rarely
|
5 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 1 Day 15, Frequency, 2=Occasionally
|
0 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 1 Day 15, Frequency, 3=Frequently
|
2 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 1 Day 15, Frequency, 4=Almost constantly
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 1, Severity, 0=None
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 1, Severity, 1=Mild
|
7 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 1, Severity, 2=Moderate
|
0 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 1, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 1, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 1, Frequency, 0=Never
|
4 Participants
|
8 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 1, Frequency, 1=Rarely
|
6 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 1, Frequency, 2=Occasionally
|
1 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 1, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 1, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 8, Severity, 0=None
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 8, Severity, 1=Mild
|
4 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 8, Severity, 2=Moderate
|
2 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 8, Severity, 3=Severe
|
2 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 8, Frequency, 0=Never
|
3 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 8, Frequency, 1=Rarely
|
3 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 8, Frequency, 2=Occasionally
|
3 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 8, Frequency, 3=Frequently
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 8, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 15, Severity, 0=None
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 15, Severity, 1=Mild
|
5 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 15, Severity, 2=Moderate
|
2 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 15, Severity, 3=Severe
|
0 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 15, Frequency, 0=Never
|
6 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 15, Frequency, 1=Rarely
|
2 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 15, Frequency, 2=Occasionally
|
4 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 15, Frequency, 3=Frequently
|
1 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 2 Day 15, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 1, Severity, 0=None
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 1, Severity, 1=Mild
|
4 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 1, Severity, 2=Moderate
|
2 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 1, Severity, 3=Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 1, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 1, Frequency, 0=Never
|
7 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 1, Frequency, 1=Rarely
|
2 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 1, Frequency, 2=Occasionally
|
2 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 1, Frequency, 3=Frequently
|
3 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 1, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 8, Severity, 0=None
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 8, Severity, 1=Mild
|
2 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 8, Severity, 2=Moderate
|
2 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 8, Severity, 3=Severe
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 8, Frequency, 0=Never
|
4 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 8, Frequency, 1=Rarely
|
2 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 8, Frequency, 2=Occasionally
|
3 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 8, Frequency, 3=Frequently
|
0 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 8, Frequency, 4=Almost constantly
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 15, Severity, 0=None
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 15, Severity, 1=Mild
|
1 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 15, Severity, 2=Moderate
|
0 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 15, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 15, Frequency, 0=Never
|
3 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 15, Frequency, 1=Rarely
|
1 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 15, Frequency, 2=Occasionally
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 15, Frequency, 3=Frequently
|
0 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Cycle 3 Day 15, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Pre-IDS Evaluation, Frequency, 0=Never
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Pre-IDS Evaluation, Frequency, 1=Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Pre-IDS Evaluation, Frequency, 2=Occasionally
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Pre-IDS Evaluation, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, Pre-IDS Evaluation, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, End Of Treatment, Severity, 0=None
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, End Of Treatment, Severity, 1=Mild
|
—
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, End Of Treatment, Severity, 2=Moderate
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, End Of Treatment, Severity, 3=Severe
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, End Of Treatment, Severity, 4=Very severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, End Of Treatment, Frequency, 0=Never
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, End Of Treatment, Frequency, 1=Rarely
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, End Of Treatment, Frequency, 2=Occasionally
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, End Of Treatment, Frequency, 3=Frequently
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Bloating of Abdomen, End Of Treatment, Frequency, 4=Almost constantly
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Baseline, Severity, 0=None
|
8 Participants
|
9 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Baseline, Severity, 1=Mild
|
3 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Baseline, Severity, 2=Moderate
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Baseline, Severity, 3=Severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Baseline, Severity, 4=Very severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 1 Day 8, Severity, 0=None
|
5 Participants
|
8 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 1 Day 8, Severity, 1=Mild
|
0 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 1 Day 8, Severity, 2=Moderate
|
3 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 1 Day 8, Severity, 3=Severe
|
3 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 1 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 1 Day 15, Severity, 0=None
|
10 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 1 Day 15, Severity, 1=Mild
|
4 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 1 Day 15, Severity, 2=Moderate
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 1 Day 15, Severity, 3=Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 1 Day 15, Severity, 4=Very severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 2 Day 1, Severity, 0=None
|
8 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 2 Day 1, Severity, 2=Moderate
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 2 Day 1, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 2 Day 1, Severity, 4=Very severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 2 Day 8, Severity, 0=None
|
6 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 2 Day 8, Severity, 1=Mild
|
2 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 2 Day 8, Severity, 2=Moderate
|
2 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 2 Day 8, Severity, 3=Severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 2 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 2 Day 1, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 2 Day 15, Severity, 0=None
|
10 Participants
|
8 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 2 Day 1, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 2 Day 8, Severity, 0=None
|
3 Participants
|
7 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 2 Day 8, Severity, 1=Mild
|
4 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 2 Day 8, Severity, 2=Moderate
|
3 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 2 Day 8, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 2 Day 8, Severity, 4=Very severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 2 Day 15, Severity, 0=None
|
4 Participants
|
9 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 2 Day 15, Severity, 1=Mild
|
8 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 2 Day 15, Severity, 1=Mild
|
3 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 2 Day 15, Severity, 2=Moderate
|
0 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 2 Day 15, Severity, 3=Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 2 Day 15, Severity, 2=Moderate
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 2 Day 15, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 2 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 3 Day 1, Severity, 0=None
|
8 Participants
|
9 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 3 Day 1, Severity, 1=Mild
|
5 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 3 Day 1, Severity, 2=Moderate
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 3 Day 1, Severity, 3=Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 3 Day 1, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 3 Day 8, Severity, 0=None
|
4 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 3 Day 8, Severity, 1=Mild
|
1 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 3 Day 8, Severity, 3=Severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 3 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 3 Day 15, Severity, 0=None
|
1 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 3 Day 15, Severity, 1=Mild
|
3 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 3 Day 15, Severity, 2=Moderate
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 3 Day 15, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 3 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Pre-IDS Evaluation, Severity, 0=None
|
2 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Pre-IDS Evaluation, Severity, 1=Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Pre-IDS Evaluation, Severity, 2=Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Pre-IDS Evaluation, Severity, 3=Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Pre-IDS Evaluation, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, End Of Treatment, Severity, 0=None
|
—
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, End Of Treatment, Severity, 1=Mild
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, End Of Treatment, Severity, 2=Moderate
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, End Of Treatment, Severity, 3=Severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, End Of Treatment, Severity, 4=Very severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Baseline, Severity, 0=None
|
7 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Baseline, Severity, 1=Mild
|
6 Participants
|
8 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Baseline, Severity, 2=Moderate
|
0 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Baseline, Severity, 3=Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Baseline, Severity, 4=Very severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 1 Day 8, Severity, 0=None
|
7 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 1 Day 8, Severity, 1=Mild
|
3 Participants
|
8 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 1 Day 8, Severity, 2=Moderate
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 1 Day 8, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 1 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 1 Day 15, Severity, 0=None
|
6 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 1 Day 15, Severity, 1=Mild
|
7 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 1 Day 15, Severity, 2=Moderate
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 1 Day 15, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 1 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 2 Day 1, Severity, 0=None
|
5 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 2 Day 1, Severity, 1=Mild
|
4 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 2 Day 1, Severity, 2=Moderate
|
2 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 2 Day 1, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 2 Day 1, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 2 Day 8, Severity, 0=None
|
5 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 2 Day 8, Severity, 1=Mild
|
5 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 2 Day 8, Severity, 2=Moderate
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 2 Day 8, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 2 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 2 Day 15, Severity, 0=None
|
6 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 2 Day 15, Severity, 1=Mild
|
7 Participants
|
7 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 2 Day 15, Severity, 2=Moderate
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 2 Day 15, Severity, 3=Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 2 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 3 Day 1, Severity, 0=None
|
8 Participants
|
9 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 3 Day 1, Severity, 1=Mild
|
6 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 2 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 3 Day 1, Severity, 0=None
|
11 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 3 Day 1, Severity, 1=Mild
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 3 Day 1, Severity, 2=Moderate
|
1 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 3 Day 1, Severity, 3=Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 3 Day 1, Severity, 4=Very severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 3 Day 8, Severity, 0=None
|
4 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 3 Day 8, Severity, 1=Mild
|
5 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 3 Day 8, Severity, 2=Moderate
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 3 Day 8, Severity, 3=Severe
|
0 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 3 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 3 Day 15, Severity, 0=None
|
4 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 3 Day 15, Severity, 1=Mild
|
1 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 3 Day 15, Severity, 2=Moderate
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 3 Day 15, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Cycle 3 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Pre-IDS Evaluation, Severity, 0=None
|
2 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Pre-IDS Evaluation, Severity, 1=Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Pre-IDS Evaluation, Severity, 2=Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Pre-IDS Evaluation, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, Pre-IDS Evaluation, Severity, 4=Very severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, End Of Treatment, Severity, 0=None
|
—
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, End Of Treatment, Severity, 1=Mild
|
—
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, End Of Treatment, Severity, 2=Moderate
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, End Of Treatment, Severity, 3=Severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation, End Of Treatment, Severity, 4=Very severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Baseline, Frequency, 0=Never
|
8 Participants
|
10 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Baseline, Frequency, 1=Rarely
|
2 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Baseline, Frequency, 2=Occasionally
|
4 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Baseline, Frequency, 3=Frequently
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Baseline, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 1 Day 8, Frequency, 0=Never
|
8 Participants
|
11 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 1 Day 8, Frequency, 1=Rarely
|
1 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 1 Day 8, Frequency, 2=Occasionally
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 1 Day 8, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 1 Day 8, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 1 Day 15, Frequency, 0=Never
|
11 Participants
|
10 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 1 Day 15, Frequency, 1=Rarely
|
2 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 1 Day 15, Frequency, 2=Occasionally
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 1 Day 15, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 1 Day 15, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 2 Day 1, Frequency, 0=Never
|
9 Participants
|
12 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 2 Day 1, Frequency, 1=Rarely
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 2 Day 1, Frequency, 2=Occasionally
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 2 Day 1, Frequency, 3=Frequently
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 2 Day 1, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 2 Day 8, Frequency, 0=Never
|
7 Participants
|
9 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 2 Day 8, Frequency, 1=Rarely
|
2 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 2 Day 8, Frequency, 2=Occasionally
|
2 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 2 Day 8, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 2 Day 8, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 2 Day 15, Frequency, 0=Never
|
8 Participants
|
12 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 2 Day 15, Frequency, 1=Rarely
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 2 Day 15, Frequency, 2=Occasionally
|
3 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 2 Day 15, Frequency, 3=Frequently
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 2 Day 15, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 3 Day 1, Frequency, 0=Never
|
8 Participants
|
12 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 3 Day 1, Frequency, 1=Rarely
|
4 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 3 Day 1, Frequency, 2=Occasionally
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 3 Day 1, Frequency, 3=Frequently
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 3 Day 1, Frequency, 4=Almost constantly
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 3 Day 8, Frequency, 0=Never
|
7 Participants
|
8 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 3 Day 8, Frequency, 1=Rarely
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 3 Day 8, Frequency, 2=Occasionally
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 3 Day 8, Frequency, 3=Frequently
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 3 Day 8, Frequency, 4=Almost constantly
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 3 Day 15, Frequency, 0=Never
|
1 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 3 Day 15, Frequency, 1=Rarely
|
2 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 3 Day 15, Frequency, 2=Occasionally
|
2 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 3 Day 15, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Cycle 3 Day 15, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Pre-IDS Evaluation, Frequency, 0=Never
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Pre-IDS Evaluation, Frequency, 1=Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Pre-IDS Evaluation, Frequency, 2=Occasionally
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Pre-IDS Evaluation, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, Pre-IDS Evaluation, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, End Of Treatment, Frequency, 0=Never
|
—
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, End Of Treatment, Frequency, 1=Rarely
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, End Of Treatment, Frequency, 2=Occasionally
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, End Of Treatment, Frequency, 3=Frequently
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Loose/Watery Stools, End Of Treatment, Frequency, 4=Almost constantly
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Baseline, Severity, 0=None
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Baseline, Severity, 1=Mild
|
6 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Baseline, Severity, 2=Moderate
|
6 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Baseline, Severity, 3=Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Baseline, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Baseline, Frequency, 0=Never
|
2 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Baseline, Frequency, 1=Rarely
|
6 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Baseline, Frequency, 2=Occasionally
|
3 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Baseline, Frequency, 3=Frequently
|
2 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Baseline, Frequency, 4=Almost constantly
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 1 Day 8, Severity, 0=None
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 1 Day 8, Severity, 1=Mild
|
4 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 1 Day 8, Severity, 2=Moderate
|
4 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 1 Day 8, Severity, 3=Severe
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 1 Day 8, Severity, 4=Very severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 1 Day 8, Frequency, 0=Never
|
1 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 1 Day 8, Frequency, 1=Rarely
|
3 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 1 Day 8, Frequency, 2=Occasionally
|
3 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 1 Day 8, Frequency, 3=Frequently
|
3 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 1 Day 8, Frequency, 4=Almost constantly
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 1 Day 15, Severity, 0=None
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 1 Day 15, Severity, 1=Mild
|
8 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 1 Day 15, Severity, 2=Moderate
|
2 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 1 Day 15, Severity, 3=Severe
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 1 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 1 Day 15, Frequency, 0=Never
|
3 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 1 Day 15, Frequency, 2=Occasionally
|
4 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 1 Day 15, Frequency, 3=Frequently
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 1 Day 15, Frequency, 4=Almost constantly
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 1, Severity, 0=None
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 1, Severity, 1=Mild
|
4 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 1, Severity, 2=Moderate
|
3 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 1, Severity, 3=Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 1, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 1, Frequency, 0=Never
|
4 Participants
|
9 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 1, Frequency, 1=Rarely
|
4 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 1, Frequency, 2=Occasionally
|
3 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 1, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 1, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 8, Severity, 0=None
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 8, Severity, 1=Mild
|
2 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 8, Severity, 2=Moderate
|
3 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 8, Severity, 3=Severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 3 Day 1, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 3 Day 1, Severity, 4=Very severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 8, Frequency, 0=Never
|
4 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 8, Frequency, 1=Rarely
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 8, Frequency, 2=Occasionally
|
4 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 8, Frequency, 3=Frequently
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 8, Frequency, 4=Almost constantly
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 15, Severity, 0=None
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 15, Severity, 1=Mild
|
7 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 15, Severity, 2=Moderate
|
0 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 15, Severity, 3=Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 3 Day 8, Severity, 0=None
|
5 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 3 Day 8, Severity, 1=Mild
|
1 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 3 Day 8, Severity, 2=Moderate
|
3 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 3 Day 8, Severity, 3=Severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 3 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 3 Day 15, Severity, 0=None
|
2 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 3 Day 15, Severity, 1=Mild
|
3 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 3 Day 15, Severity, 2=Moderate
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 3 Day 15, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Cycle 3 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Pre-IDS Evaluation, Severity, 0=None
|
2 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Pre-IDS Evaluation, Severity, 1=Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 15, Frequency, 0=Never
|
6 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 15, Frequency, 1=Rarely
|
1 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 15, Frequency, 2=Occasionally
|
6 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 15, Frequency, 3=Frequently
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 2 Day 15, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 1, Severity, 0=None
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 1, Severity, 1=Mild
|
4 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 1, Severity, 2=Moderate
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 1, Severity, 3=Severe
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 1, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 1, Frequency, 0=Never
|
6 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 1, Frequency, 1=Rarely
|
3 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 1, Frequency, 2=Occasionally
|
3 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 1, Frequency, 3=Frequently
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 1, Frequency, 4=Almost constantly
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 8, Severity, 0=None
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 8, Severity, 1=Mild
|
4 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 8, Severity, 2=Moderate
|
2 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 8, Severity, 3=Severe
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 8, Frequency, 0=Never
|
2 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 8, Frequency, 1=Rarely
|
3 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 8, Frequency, 2=Occasionally
|
2 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 8, Frequency, 3=Frequently
|
3 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 8, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 15, Severity, 0=None
|
2 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 15, Severity, 1=Mild
|
2 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 15, Severity, 2=Moderate
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 15, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 15, Frequency, 0=Never
|
0 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 15, Frequency, 1=Rarely
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 15, Frequency, 2=Occasionally
|
3 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 15, Frequency, 3=Frequently
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Cycle 3 Day 15, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Pre-IDS Evaluation, Frequency, 0=Never
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Pre-IDS Evaluation, Frequency, 1=Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Pre-IDS Evaluation, Frequency, 2=Occasionally
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Pre-IDS Evaluation, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, Pre-IDS Evaluation, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, End Of Treatment, Severity, 0=None
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, End Of Treatment, Severity, 1=Mild
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, End Of Treatment, Severity, 2=Moderate
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, End Of Treatment, Severity, 3=Severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, End Of Treatment, Frequency, 0=Never
|
—
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, End Of Treatment, Frequency, 1=Rarely
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, End Of Treatment, Frequency, 2=Occasionally
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, End Of Treatment, Frequency, 3=Frequently
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain in the Abdomen, End Of Treatment, Frequency, 4=Almost constantly
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Baseline, Severity, 0=None
|
7 Participants
|
15 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Baseline, Severity, 1=Mild
|
4 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Baseline, Severity, 2=Moderate
|
2 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Baseline, Severity, 3=Severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Baseline, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 1 Day 8, Severity, 0=None
|
5 Participants
|
11 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 1 Day 8, Severity, 1=Mild
|
2 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 1 Day 8, Severity, 2=Moderate
|
2 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 1 Day 8, Severity, 3=Severe
|
2 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 1 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 1 Day 15, Severity, 0=None
|
5 Participants
|
11 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 1 Day 15, Severity, 1=Mild
|
6 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 1 Day 15, Severity, 2=Moderate
|
3 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 1 Day 15, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 1 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 2 Day 1, Severity, 0=None
|
6 Participants
|
14 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 2 Day 1, Severity, 1=Mild
|
2 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 2 Day 1, Severity, 2=Moderate
|
3 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 2 Day 1, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 2 Day 1, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 2 Day 8, Severity, 0=None
|
2 Participants
|
10 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 2 Day 8, Severity, 1=Mild
|
5 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 2 Day 8, Severity, 2=Moderate
|
2 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 2 Day 8, Severity, 3=Severe
|
2 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 2 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 2 Day 15, Severity, 0=None
|
1 Participants
|
13 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 2 Day 15, Severity, 1=Mild
|
5 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 2 Day 15, Severity, 2=Moderate
|
5 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 2 Day 15, Severity, 3=Severe
|
2 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 2 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 3 Day 1, Severity, 0=None
|
3 Participants
|
13 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 3 Day 1, Severity, 1=Mild
|
8 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 3 Day 1, Severity, 2=Moderate
|
3 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 3 Day 1, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 3 Day 1, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 3 Day 8, Severity, 0=None
|
1 Participants
|
8 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 3 Day 8, Severity, 1=Mild
|
2 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 3 Day 8, Severity, 2=Moderate
|
5 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 3 Day 8, Severity, 3=Severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 3 Day 8, Severity, 4=Very severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 3 Day 15, Severity, 0=None
|
0 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 3 Day 15, Severity, 1=Mild
|
3 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 3 Day 15, Severity, 2=Moderate
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 3 Day 15, Severity, 3=Severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Cycle 3 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Pre-IDS Evaluation, Severity, 0=None
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Pre-IDS Evaluation, Severity, 1=Mild
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Pre-IDS Evaluation, Severity, 2=Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Pre-IDS Evaluation, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, Pre-IDS Evaluation, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, End Of Treatment, Severity, 0=None
|
—
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, End Of Treatment, Severity, 1=Mild
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, End Of Treatment, Severity, 2=Moderate
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, End Of Treatment, Severity, 3=Severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numb/Tingling Hands/Feet, End Of Treatment, Severity, 4=Very severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Baseline, Severity, 0=None
|
4 Participants
|
7 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Baseline, Severity, 1=Mild
|
8 Participants
|
7 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Baseline, Severity, 2=Moderate
|
1 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Baseline, Severity, 3=Severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Baseline, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 1 Day 8, Severity, 0=None
|
3 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 1 Day 8, Severity, 1=Mild
|
2 Participants
|
10 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 1 Day 8, Severity, 2=Moderate
|
6 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 1 Day 8, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 1 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 1 Day 15, Severity, 0=None
|
7 Participants
|
7 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 1 Day 15, Severity, 1=Mild
|
5 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 1 Day 15, Severity, 2=Moderate
|
2 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 1 Day 15, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 1 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 2 Day 1, Severity, 0=None
|
5 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 2 Day 1, Severity, 1=Mild
|
4 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Probs w/Concentration, Cycle 2 Day 1, Severity, 2=Moderate
|
2 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Pre-IDS Evaluation, Severity, 2=Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Pre-IDS Evaluation, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, Pre-IDS Evaluation, Severity, 4=Very severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, End Of Treatment, Severity, 0=None
|
—
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, End Of Treatment, Severity, 1=Mild
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, End Of Treatment, Severity, 2=Moderate
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, End Of Treatment, Severity, 3=Severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Problems w/Memory, End Of Treatment, Severity, 4=Very severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Baseline, Severity, 0=None
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Baseline, Severity, 1=Mild
|
0 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Baseline, Severity, 2=Moderate
|
1 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Baseline, Severity, 3=Severe
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Baseline, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Baseline, Frequency, 0=Never
|
11 Participants
|
7 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Baseline, Severity, 3=Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Baseline, Frequency, 1=Rarely
|
1 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Baseline, Frequency, 2=Occasionally
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Baseline, Frequency, 3=Frequently
|
0 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Baseline, Frequency, 4=Almost constantly
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 1 Day 8, Severity, 0=None
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 1 Day 8, Severity, 1=Mild
|
1 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 1 Day 8, Severity, 2=Moderate
|
2 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 1 Day 8, Severity, 3=Severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 1 Day 8, Severity, 4=Very severe
|
4 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 1 Day 8, Frequency, 0=Never
|
2 Participants
|
8 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 1 Day 8, Frequency, 1=Rarely
|
2 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 1 Day 8, Frequency, 2=Occasionally
|
2 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 1 Day 8, Frequency, 3=Frequently
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 1 Day 8, Frequency, 4=Almost constantly
|
4 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 1 Day 15, Severity, 0=None
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 1 Day 15, Severity, 1=Mild
|
5 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 1 Day 15, Severity, 2=Moderate
|
2 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 1 Day 15, Severity, 3=Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 1 Day 15, Severity, 4=Very severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 1 Day 15, Frequency, 0=Never
|
5 Participants
|
8 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 1 Day 15, Frequency, 1=Rarely
|
3 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 1 Day 15, Frequency, 2=Occasionally
|
5 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 1 Day 15, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 1 Day 15, Frequency, 4=Almost constantly
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 1, Severity, 0=None
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 1, Severity, 1=Mild
|
3 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 1, Severity, 2=Moderate
|
0 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 1, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 1, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 1, Frequency, 0=Never
|
8 Participants
|
8 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 1, Frequency, 1=Rarely
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 1, Frequency, 2=Occasionally
|
2 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 1, Frequency, 3=Frequently
|
0 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 1, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 8, Severity, 0=None
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 8, Severity, 1=Mild
|
3 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 8, Severity, 2=Moderate
|
4 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 8, Severity, 3=Severe
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 8, Severity, 4=Very severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 8, Frequency, 0=Never
|
1 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 8, Frequency, 1=Rarely
|
4 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 8, Frequency, 2=Occasionally
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 8, Frequency, 3=Frequently
|
4 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 8, Frequency, 4=Almost constantly
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 15, Severity, 0=None
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 15, Severity, 1=Mild
|
5 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 15, Severity, 2=Moderate
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 15, Severity, 3=Severe
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 15, Severity, 4=Very severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 15, Frequency, 0=Never
|
4 Participants
|
7 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 15, Frequency, 1=Rarely
|
3 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 15, Frequency, 2=Occasionally
|
4 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 15, Frequency, 3=Frequently
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 2 Day 15, Frequency, 4=Almost constantly
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 1, Severity, 0=None
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 1, Severity, 1=Mild
|
5 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 1, Severity, 2=Moderate
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 1, Severity, 3=Severe
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 1, Severity, 4=Very severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 1, Frequency, 0=Never
|
5 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 1, Frequency, 1=Rarely
|
5 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 1, Frequency, 2=Occasionally
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 1, Frequency, 3=Frequently
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 1, Frequency, 4=Almost constantly
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 8, Severity, 0=None
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 8, Severity, 1=Mild
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 8, Severity, 2=Moderate
|
2 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 8, Severity, 3=Severe
|
3 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 8, Frequency, 0=Never
|
4 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 8, Frequency, 1=Rarely
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 8, Frequency, 2=Occasionally
|
2 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 8, Frequency, 3=Frequently
|
3 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 8, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 15, Severity, 0=None
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 15, Severity, 1=Mild
|
1 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 15, Severity, 2=Moderate
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 15, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 15, Frequency, 0=Never
|
2 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 15, Frequency, 1=Rarely
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 15, Frequency, 2=Occasionally
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 15, Frequency, 3=Frequently
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Cycle 3 Day 15, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Pre-IDS Evaluation, Severity, 0=None
|
0 Participants
|
—
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Pre-IDS Evaluation, Severity, 1=Mild
|
1 Participants
|
—
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Pre-IDS Evaluation, Severity, 2=Moderate
|
0 Participants
|
—
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Pre-IDS Evaluation, Severity, 3=Severe
|
0 Participants
|
—
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Pre-IDS Evaluation, Severity, 4=Very severe
|
0 Participants
|
—
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Pre-IDS Evaluation, Frequency, 0=Never
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Pre-IDS Evaluation, Frequency, 1=Rarely
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Pre-IDS Evaluation, Frequency, 2=Occasionally
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Pre-IDS Evaluation, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, Pre-IDS Evaluation, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, End Of Treatment, Severity, 0=None
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, End Of Treatment, Severity, 1=Mild
|
—
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, End Of Treatment, Severity, 2=Moderate
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, End Of Treatment, Severity, 3=Severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, End Of Treatment, Severity, 4=Very severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, End Of Treatment, Frequency, 0=Never
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, End Of Treatment, Frequency, 1=Rarely
|
—
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, End Of Treatment, Frequency, 2=Occasionally
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, End Of Treatment, Frequency, 3=Frequently
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Muscles, End Of Treatment, Frequency, 4=Almost constantly
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Baseline, Severity, 0=None
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Baseline, Severity, 1=Mild
|
3 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Baseline, Severity, 2=Moderate
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Baseline, Severity, 3=Severe
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Baseline, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Baseline, Frequency, 0=Never
|
9 Participants
|
11 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Baseline, Frequency, 1=Rarely
|
3 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Baseline, Frequency, 2=Occasionally
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Baseline, Frequency, 3=Frequently
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Baseline, Frequency, 4=Almost constantly
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 1 Day 8, Severity, 0=None
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 1 Day 8, Severity, 1=Mild
|
3 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 1 Day 8, Severity, 2=Moderate
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 1 Day 8, Severity, 3=Severe
|
3 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 1 Day 8, Severity, 4=Very severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 1 Day 8, Frequency, 0=Never
|
3 Participants
|
12 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 1 Day 8, Frequency, 1=Rarely
|
4 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 1 Day 8, Frequency, 2=Occasionally
|
0 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 1 Day 8, Frequency, 3=Frequently
|
2 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 1 Day 8, Frequency, 4=Almost constantly
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 1 Day 15, Severity, 0=None
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 1 Day 15, Severity, 1=Mild
|
4 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 1 Day 15, Severity, 2=Moderate
|
2 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 1 Day 15, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 1 Day 15, Severity, 4=Very severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 1 Day 15, Frequency, 0=Never
|
7 Participants
|
8 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 1 Day 15, Frequency, 1=Rarely
|
4 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 1 Day 15, Frequency, 2=Occasionally
|
2 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 1 Day 15, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 1 Day 15, Frequency, 4=Almost constantly
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 1, Severity, 0=None
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 1, Severity, 1=Mild
|
4 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 1, Severity, 2=Moderate
|
1 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 1, Severity, 3=Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 1, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 1, Frequency, 0=Never
|
5 Participants
|
8 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 1, Frequency, 1=Rarely
|
4 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 1, Frequency, 2=Occasionally
|
1 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 1, Frequency, 3=Frequently
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 1, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 8, Severity, 0=None
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 8, Severity, 1=Mild
|
2 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 8, Severity, 2=Moderate
|
4 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 8, Severity, 3=Severe
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 8, Severity, 4=Very severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 8, Frequency, 0=Never
|
1 Participants
|
7 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 8, Frequency, 1=Rarely
|
3 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 8, Frequency, 2=Occasionally
|
4 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 8, Frequency, 3=Frequently
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 8, Frequency, 4=Almost constantly
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 15, Severity, 0=None
|
2 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 15, Severity, 1=Mild
|
5 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 15, Severity, 2=Moderate
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 15, Severity, 3=Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 15, Severity, 4=Very severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 15, Frequency, 0=Never
|
3 Participants
|
9 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 15, Frequency, 1=Rarely
|
5 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 15, Frequency, 2=Occasionally
|
3 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 15, Frequency, 3=Frequently
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 2 Day 15, Frequency, 4=Almost constantly
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 1, Severity, 0=None
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 1, Severity, 1=Mild
|
3 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 1, Severity, 2=Moderate
|
4 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 1, Severity, 3=Severe
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 1, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 1, Frequency, 0=Never
|
6 Participants
|
8 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 1, Frequency, 1=Rarely
|
3 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 1, Frequency, 2=Occasionally
|
3 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 1, Frequency, 3=Frequently
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 1, Frequency, 4=Almost constantly
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 8, Severity, 0=None
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 8, Severity, 1=Mild
|
0 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 8, Severity, 2=Moderate
|
2 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 8, Severity, 3=Severe
|
3 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 8, Frequency, 0=Never
|
4 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 8, Frequency, 1=Rarely
|
1 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 8, Frequency, 2=Occasionally
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 8, Frequency, 3=Frequently
|
4 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 8, Frequency, 4=Almost constantly
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 15, Severity, 0=None
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 15, Severity, 1=Mild
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 15, Severity, 2=Moderate
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 15, Severity, 3=Severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 15, Frequency, 0=Never
|
1 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 15, Frequency, 1=Rarely
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 15, Frequency, 2=Occasionally
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 15, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Cycle 3 Day 15, Frequency, 4=Almost constantly
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Pre-IDS Evaluation, Frequency, 0=Never
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Pre-IDS Evaluation, Frequency, 1=Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Pre-IDS Evaluation, Frequency, 2=Occasionally
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Pre-IDS Evaluation, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, Pre-IDS Evaluation, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, End Of Treatment, Severity, 0=None
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, End Of Treatment, Severity, 1=Mild
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, End Of Treatment, Severity, 2=Moderate
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, End Of Treatment, Severity, 3=Severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, End Of Treatment, Severity, 4=Very severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, End Of Treatment, Frequency, 0=Never
|
—
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, End Of Treatment, Frequency, 1=Rarely
|
—
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, End Of Treatment, Frequency, 2=Occasionally
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, End Of Treatment, Frequency, 3=Frequently
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Aching Joints, End Of Treatment, Frequency, 4=Almost constantly
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Baseline, Severity, 0=None
|
3 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Baseline, Severity, 1=Mild
|
2 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Baseline, Severity, 2=Moderate
|
8 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Baseline, Severity, 3=Severe
|
1 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Baseline, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 1 Day 8, Severity, 0=None
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 1 Day 8, Severity, 2=Moderate
|
3 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 1 Day 8, Severity, 3=Severe
|
7 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 1 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 1 Day 15, Severity, 0=None
|
2 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 1 Day 15, Severity, 1=Mild
|
5 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 1 Day 15, Severity, 2=Moderate
|
5 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 1 Day 15, Severity, 3=Severe
|
1 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 1 Day 15, Severity, 4=Very severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 2 Day 1, Severity, 0=None
|
3 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 2 Day 1, Severity, 1=Mild
|
4 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 2 Day 1, Severity, 2=Moderate
|
4 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 2 Day 1, Severity, 3=Severe
|
0 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 2 Day 1, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 2 Day 8, Severity, 0=None
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 2 Day 8, Severity, 1=Mild
|
4 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 2 Day 8, Severity, 2=Moderate
|
3 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 2 Day 8, Severity, 3=Severe
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 2 Day 8, Severity, 4=Very severe
|
2 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 2 Day 15, Severity, 0=None
|
2 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 2 Day 15, Severity, 1=Mild
|
2 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 2 Day 15, Severity, 2=Moderate
|
7 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 2 Day 15, Severity, 3=Severe
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 2 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 3 Day 1, Severity, 0=None
|
2 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 3 Day 1, Severity, 1=Mild
|
7 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 3 Day 1, Severity, 2=Moderate
|
5 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 3 Day 1, Severity, 3=Severe
|
0 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 3 Day 1, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 3 Day 8, Severity, 0=None
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 3 Day 8, Severity, 1=Mild
|
2 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 3 Day 8, Severity, 2=Moderate
|
3 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 3 Day 8, Severity, 3=Severe
|
3 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 3 Day 8, Severity, 4=Very severe
|
2 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 3 Day 15, Severity, 0=None
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 3 Day 15, Severity, 1=Mild
|
4 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 3 Day 15, Severity, 2=Moderate
|
1 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 3 Day 15, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Cycle 3 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Pre-IDS Evaluation, Severity, 0=None
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Pre-IDS Evaluation, Severity, 1=Mild
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Pre-IDS Evaluation, Severity, 2=Moderate
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Pre-IDS Evaluation, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, Pre-IDS Evaluation, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, End Of Treatment, Severity, 0=None
|
—
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, End Of Treatment, Severity, 1=Mild
|
—
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, End Of Treatment, Severity, 2=Moderate
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, End Of Treatment, Severity, 3=Severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue/Lack of Energy, End Of Treatment, Severity, 4=Very severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Baseline, Severity, 4=Very severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Baseline, Frequency, 0=Never
|
4 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Baseline, Frequency, 1=Rarely
|
4 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Baseline, Frequency, 2=Occasionally
|
5 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Baseline, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Baseline, Frequency, 4=Almost constantly
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 1 Day 8, Severity, 0=None
|
2 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 1 Day 8, Severity, 1=Mild
|
4 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 1 Day 8, Severity, 2=Moderate
|
1 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 1 Day 8, Severity, 3=Severe
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 1 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 1 Day 8, Frequency, 0=Never
|
3 Participants
|
7 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 1 Day 8, Frequency, 1=Rarely
|
6 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 1 Day 15, Severity, 0=None
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 1 Day 8, Frequency, 2=Occasionally
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 1 Day 8, Frequency, 3=Frequently
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 1 Day 8, Frequency, 4=Almost constantly
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 1 Day 15, Severity, 1=Mild
|
4 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 1 Day 15, Severity, 2=Moderate
|
2 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 1 Day 15, Severity, 3=Severe
|
0 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 1 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 1 Day 15, Frequency, 0=Never
|
7 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 1 Day 15, Frequency, 1=Rarely
|
6 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 1 Day 15, Frequency, 2=Occasionally
|
0 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 1 Day 15, Frequency, 3=Frequently
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 1 Day 15, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 1, Severity, 0=None
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 1, Severity, 1=Mild
|
4 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 1, Severity, 2=Moderate
|
2 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 1, Severity, 3=Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 1, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 1, Frequency, 0=Never
|
5 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 1, Frequency, 1=Rarely
|
4 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 1, Frequency, 2=Occasionally
|
2 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 15, Severity, 0=None
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 1, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 1, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 8, Severity, 0=None
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 8, Severity, 1=Mild
|
2 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 8, Severity, 2=Moderate
|
3 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 8, Severity, 3=Severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 8, Frequency, 0=Never
|
4 Participants
|
7 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 8, Frequency, 1=Rarely
|
2 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 15, Severity, 1=Mild
|
4 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 8, Frequency, 2=Occasionally
|
4 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 8, Frequency, 3=Frequently
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 8, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 15, Severity, 2=Moderate
|
4 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 15, Severity, 3=Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 15, Frequency, 0=Never
|
5 Participants
|
8 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 15, Frequency, 1=Rarely
|
2 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 15, Frequency, 2=Occasionally
|
6 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 15, Frequency, 3=Frequently
|
0 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 2 Day 15, Frequency, 4=Almost constantly
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 1, Severity, 0=None
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 1, Severity, 1=Mild
|
7 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 1, Severity, 2=Moderate
|
1 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 1, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 1, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 1, Frequency, 0=Never
|
5 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 1, Frequency, 1=Rarely
|
5 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 1, Frequency, 2=Occasionally
|
4 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 1, Frequency, 3=Frequently
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 15, Severity, 1=Mild
|
1 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 1, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 8, Severity, 0=None
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 8, Severity, 1=Mild
|
1 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 8, Severity, 2=Moderate
|
3 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 8, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 8, Frequency, 0=Never
|
5 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 8, Frequency, 1=Rarely
|
1 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 8, Frequency, 2=Occasionally
|
2 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 8, Frequency, 3=Frequently
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 8, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 15, Severity, 0=None
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 15, Severity, 2=Moderate
|
2 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 15, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 15, Frequency, 0=Never
|
1 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 15, Frequency, 1=Rarely
|
2 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 15, Frequency, 2=Occasionally
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 15, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Cycle 3 Day 15, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Pre-IDS Evaluation, Severity, 0=None
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Pre-IDS Evaluation, Severity, 1=Mild
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Pre-IDS Evaluation, Severity, 2=Moderate
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Pre-IDS Evaluation, Severity, 3=Severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Pre-IDS Evaluation, Severity, 4=Very severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Pre-IDS Evaluation, Frequency, 0=Never
|
2 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Pre-IDS Evaluation, Frequency, 1=Rarely
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Pre-IDS Evaluation, Frequency, 2=Occasionally
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Pre-IDS Evaluation, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, Pre-IDS Evaluation, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, End Of Treatment, Severity, 0=None
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, End Of Treatment, Severity, 1=Mild
|
—
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, End Of Treatment, Severity, 2=Moderate
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, End Of Treatment, Severity, 3=Severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, End Of Treatment, Severity, 4=Very severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, End Of Treatment, Frequency, 0=Never
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, End Of Treatment, Frequency, 1=Rarely
|
—
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, End Of Treatment, Frequency, 2=Occasionally
|
—
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, End Of Treatment, Frequency, 3=Frequently
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxiety, End Of Treatment, Frequency, 4=Almost constantly
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Baseline, Severity, 0=None
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Baseline, Severity, 1=Mild
|
8 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Baseline, Severity, 2=Moderate
|
3 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Baseline, Severity, 3=Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Baseline, Severity, 4=Very severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Baseline, Frequency, 0=Never
|
2 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Baseline, Frequency, 1=Rarely
|
4 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Baseline, Frequency, 2=Occasionally
|
8 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Baseline, Frequency, 3=Frequently
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Baseline, Frequency, 4=Almost constantly
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 1 Day 8, Severity, 0=None
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 1 Day 8, Severity, 1=Mild
|
6 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 1 Day 8, Severity, 2=Moderate
|
2 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 1 Day 8, Severity, 3=Severe
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 1 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 1 Day 8, Frequency, 0=Never
|
1 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 1 Day 8, Frequency, 1=Rarely
|
5 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 1 Day 8, Frequency, 2=Occasionally
|
4 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 1 Day 8, Frequency, 3=Frequently
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 1 Day 8, Frequency, 4=Almost constantly
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 1 Day 15, Severity, 0=None
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 1 Day 15, Severity, 1=Mild
|
5 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 1 Day 15, Severity, 2=Moderate
|
2 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 1 Day 15, Severity, 3=Severe
|
0 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 1 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 1 Day 15, Frequency, 0=Never
|
6 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 1 Day 15, Frequency, 1=Rarely
|
5 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 1 Day 15, Frequency, 2=Occasionally
|
2 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 1 Day 15, Frequency, 3=Frequently
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 1 Day 15, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 1, Severity, 0=None
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 1, Severity, 1=Mild
|
3 Participants
|
7 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 1, Severity, 2=Moderate
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 1, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 1, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 1, Frequency, 0=Never
|
6 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 1, Frequency, 1=Rarely
|
1 Participants
|
8 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 1, Frequency, 2=Occasionally
|
4 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 1, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 1, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 8, Severity, 0=None
|
1 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 8, Severity, 1=Mild
|
3 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 8, Severity, 2=Moderate
|
2 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 8, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 8, Severity, 4=Very severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 8, Frequency, 0=Never
|
4 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 8, Frequency, 1=Rarely
|
3 Participants
|
8 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 8, Frequency, 2=Occasionally
|
2 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 8, Frequency, 3=Frequently
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 8, Frequency, 4=Almost constantly
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 15, Severity, 0=None
|
0 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 15, Severity, 1=Mild
|
5 Participants
|
6 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 15, Severity, 2=Moderate
|
4 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 15, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 15, Frequency, 0=Never
|
4 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 15, Frequency, 1=Rarely
|
4 Participants
|
7 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 15, Frequency, 2=Occasionally
|
4 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 15, Frequency, 3=Frequently
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 2 Day 15, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 1, Severity, 0=None
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 1, Severity, 1=Mild
|
6 Participants
|
8 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 1, Severity, 2=Moderate
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 1, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 1, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 1, Frequency, 0=Never
|
6 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 1, Frequency, 1=Rarely
|
6 Participants
|
9 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 1, Frequency, 2=Occasionally
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 1, Frequency, 3=Frequently
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 1, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 8, Severity, 0=None
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 8, Severity, 1=Mild
|
0 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 8, Severity, 2=Moderate
|
2 Participants
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 8, Severity, 3=Severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 8, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 8, Frequency, 0=Never
|
5 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 8, Frequency, 1=Rarely
|
2 Participants
|
5 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 8, Frequency, 2=Occasionally
|
2 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 8, Frequency, 3=Frequently
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 8, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 15, Severity, 0=None
|
1 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 15, Severity, 1=Mild
|
4 Participants
|
4 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 15, Severity, 2=Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 15, Severity, 3=Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 15, Severity, 4=Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 15, Frequency, 0=Never
|
0 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 15, Frequency, 1=Rarely
|
4 Participants
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 15, Frequency, 2=Occasionally
|
1 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 15, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Cycle 3 Day 15, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Pre-IDS Evaluation, Severity, 0=None
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Pre-IDS Evaluation, Severity, 1=Mild
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Pre-IDS Evaluation, Severity, 2=Moderate
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Pre-IDS Evaluation, Severity, 3=Severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Pre-IDS Evaluation, Severity, 4=Very severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Pre-IDS Evaluation, Frequency, 0=Never
|
2 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Pre-IDS Evaluation, Frequency, 1=Rarely
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Pre-IDS Evaluation, Frequency, 2=Occasionally
|
0 Participants
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Pre-IDS Evaluation, Frequency, 3=Frequently
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, Pre-IDS Evaluation, Frequency, 4=Almost constantly
|
0 Participants
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, End Of Treatment, Severity, 0=None
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, End Of Treatment, Severity, 1=Mild
|
—
|
1 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, End Of Treatment, Severity, 2=Moderate
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, End Of Treatment, Severity, 3=Severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, End Of Treatment, Severity, 4=Very severe
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, End Of Treatment, Frequency, 0=Never
|
—
|
3 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, End Of Treatment, Frequency, 1=Rarely
|
—
|
2 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, End Of Treatment, Frequency, 2=Occasionally
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, End Of Treatment, Frequency, 3=Frequently
|
—
|
0 Participants
|
|
Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Sad or Unhappy Feelings, End Of Treatment, Frequency, 4=Almost constantly
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Predose), Day 8 and 15 of Cycle 1; Day 1, 8, and 15 of Cycle 2 and Cycle 3; Pre-IDS Evaluation, and End of Treatment (Up to approximately 154 weeks)Population: Intent to Treat Population is included as the Overall Number of Participants Analyzed. 'Number Analyzed' refers to participants evaluable at the specified time points. The "0" participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups.
The FACT-GP5 item is a single item from the FACT-G that assesses how bothersome the side effects of treatment are for participants with cancer. It evaluates the extent to which side effects of treatment are bothersome for cancer participants. This outcome is measured using a 5-category response scale, where responses include 0="Not at all," 1="A little bit," 2="Somewhat," 3="Quite a bit," and 4="Very much." A higher score on this measure indicates that the participant experiences a greater level of bother from the side effects of treatment.
Outcome measures
| Measure |
Platinum-taxane
n=17 Participants
Participants with ovarian cancer received platinum-taxane doublet chemotherapy as solution for intravenous infusion for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent interval debulking surgery (IDS) with recovery period of up to 6 weeks. After IDS, all participants received another three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional followed by niraparib maintenance treatment for up to 36 months or until an adverse event (AE), progression of disease (PD) per RECIST v1.1.
|
Niraparib
n=19 Participants
Participants with ovarian cancer received 100 milligram (mg) Niraparib capsules orally for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent IDS with recovery period of up to 6 weeks. After IDS, all participants received three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional, followed by niraparib maintenance treatment for up to 36 months or until an AE, PD per RECIST v1.1. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelets count ≥ 150000 cells per microliter were administered 300 mg of Niraparib. Participants with screening actual body weight less than 77 kg or screening platelets count less than 150000 cells per microliter were administered 200 mg of niraparib.
|
|---|---|---|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 1 Day 8, 0=Not at all
|
0 Participants
|
2 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 1 Day 8, 1=A little bit
|
2 Participants
|
5 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 1 Day 8, 2=Somewhat
|
2 Participants
|
7 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 1 Day 8, 3=Quite a bit
|
6 Participants
|
1 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 1 Day 8, 4=Very much
|
1 Participants
|
0 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 1 Day 15, 0=Not at all
|
4 Participants
|
5 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 1 Day 15, 1=A little bit
|
2 Participants
|
2 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 1 Day 15, 2=Somewhat
|
4 Participants
|
7 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 1 Day 15, 3=Quite a bit
|
2 Participants
|
0 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 1 Day 15, 4=Very much
|
2 Participants
|
0 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 2 Day 1, 0=Not at all
|
4 Participants
|
5 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 2 Day 1, 1=A little bit
|
4 Participants
|
2 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 2 Day 1, 2=Somewhat
|
2 Participants
|
5 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 2 Day 1, 3=Quite a bit
|
1 Participants
|
2 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 2 Day 1, 4=Very much
|
0 Participants
|
0 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 2 Day 8, 0=Not at all
|
1 Participants
|
3 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 2 Day 8, 1=A little bit
|
4 Participants
|
3 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 2 Day 8, 2=Somewhat
|
3 Participants
|
6 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 2 Day 8, 3=Quite a bit
|
1 Participants
|
0 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 2 Day 8, 4=Very much
|
2 Participants
|
0 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 2 Day 15, 0=Not at all
|
2 Participants
|
4 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 2 Day 15, 1=A little bit
|
3 Participants
|
5 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 2 Day 15, 2=Somewhat
|
5 Participants
|
4 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 2 Day 15, 3=Quite a bit
|
2 Participants
|
1 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 2 Day 15, 4=Very much
|
1 Participants
|
0 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 3 Day 1, 0=Not at all
|
1 Participants
|
4 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 3 Day 1, 1=A little bit
|
9 Participants
|
3 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 3 Day 1, 2=Somewhat
|
4 Participants
|
6 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 3 Day 1, 3=Quite a bit
|
0 Participants
|
1 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 3 Day 1, 4=Very much
|
0 Participants
|
0 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 3 Day 8, 0=Not at all
|
1 Participants
|
1 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 3 Day 8, 1=A little bit
|
3 Participants
|
3 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 3 Day 8, 2=Somewhat
|
0 Participants
|
6 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 3 Day 8, 3=Quite a bit
|
5 Participants
|
0 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 3 Day 8, 4=Very much
|
1 Participants
|
0 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 3 Day 15, 0=Not at all
|
0 Participants
|
2 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 3 Day 15, 1=A little bit
|
3 Participants
|
2 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 3 Day 15, 2=Somewhat
|
1 Participants
|
3 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 3 Day 15, 3=Quite a bit
|
1 Participants
|
0 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Cycle 3 Day 15, 4=Very much
|
0 Participants
|
0 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Pre-IDS Evaluation, 0=Not at all
|
2 Participants
|
2 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Pre-IDS Evaluation, 1=A little bit
|
7 Participants
|
1 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Pre-IDS Evaluation, 2=Somewhat
|
6 Participants
|
4 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Pre-IDS Evaluation, 3=Quite a bit
|
0 Participants
|
0 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Pre-IDS Evaluation, 4=Very much
|
0 Participants
|
0 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
End Of Treatment, 0=Not at all
|
—
|
2 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Baseline, 1=A little bit
|
4 Participants
|
6 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Baseline, 2=Somewhat
|
1 Participants
|
7 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Baseline, 3=Quite a bit
|
4 Participants
|
0 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Baseline, 4=Very much
|
1 Participants
|
0 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
Baseline, 0=Not at all
|
4 Participants
|
4 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
End Of Treatment, 1=A little bit
|
—
|
1 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
End Of Treatment, 2=Somewhat
|
—
|
2 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
End Of Treatment, 3=Quite a bit
|
—
|
0 Participants
|
|
Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5
End Of Treatment, 4=Very much
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Predose), Day 1 of Cycle 2 and Cycle 3; Pre-IDS Evaluation, and End of Treatment (Up to approximately 154 weeks).Population: Intent to Treat Population is included as the Overall Number of Participants Analyzed. 'Number Analyzed' refers to participants evaluable at the specified time points. The "0" participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups.
EORTC IL136 includes items from the EORTC QLQ-C30, a 30-item survey assessing health-related quality of life (HRQoL) in cancer patients, featuring 5 functional scales, 3 symptom scales, 6 single items, and a global health status/HRQoL scale. Functional and symptom scales/items are rated on 4-point scale with options "Not at all," "A little," "Quite a bit," and "Very much". 2 items measuring global health status/quality of life use a 7-point scale ranging from 1 ("Very Poor") to 7 ("Excellent"). Each item has a specific scoring system, and scores were transformed to a 0-100 scale, where higher scores on functional scales and global health status/HRQoL scale indicate better functioning or quality of life, while higher scores on symptom scales/items indicate greater symptom burden. Baseline is defined as the latest assessment with a non-missing value prior to Cycle 1 Day 1 (C1D1), including those from unscheduled visits.
Outcome measures
| Measure |
Platinum-taxane
n=17 Participants
Participants with ovarian cancer received platinum-taxane doublet chemotherapy as solution for intravenous infusion for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent interval debulking surgery (IDS) with recovery period of up to 6 weeks. After IDS, all participants received another three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional followed by niraparib maintenance treatment for up to 36 months or until an adverse event (AE), progression of disease (PD) per RECIST v1.1.
|
Niraparib
n=19 Participants
Participants with ovarian cancer received 100 milligram (mg) Niraparib capsules orally for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent IDS with recovery period of up to 6 weeks. After IDS, all participants received three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional, followed by niraparib maintenance treatment for up to 36 months or until an AE, PD per RECIST v1.1. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelets count ≥ 150000 cells per microliter were administered 300 mg of Niraparib. Participants with screening actual body weight less than 77 kg or screening platelets count less than 150000 cells per microliter were administered 200 mg of niraparib.
|
|---|---|---|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Social Functioning Scale, CFB to CYCLE 2 DAY 1
|
13.64 Scores on scale
Standard Deviation 27.707
|
7.58 Scores on scale
Standard Deviation 36.027
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Social Functioning Scale, CFB to CYCLE 3 DAY 1
|
13.89 Scores on scale
Standard Deviation 30.841
|
1.85 Scores on scale
Standard Deviation 22.737
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Social Functioning Scale, CFB to Pre-IDS EVALUATION
|
7.14 Scores on scale
Standard Deviation 27.514
|
8.33 Scores on scale
Standard Deviation 25.276
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Social Functioning Scale, CFB to END OF TREATMENT
|
—
|
3.33 Scores on scale
Standard Deviation 18.257
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Cond Interfere With Family Life, CFB to CYCLE 2 DAY 1
|
18.18 Scores on scale
Standard Deviation 31.140
|
6.06 Scores on scale
Standard Deviation 44.267
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Cond Interfere With Family Life, CFB to CYCLE 3 DAY 1
|
13.89 Scores on scale
Standard Deviation 33.207
|
-7.41 Scores on scale
Standard Deviation 27.778
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Cond Interfere With Family Life, CFB to Pre-IDS EVALUATION
|
14.29 Scores on scale
Standard Deviation 36.314
|
-5.56 Scores on scale
Standard Deviation 38.968
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Cond Interfere With Family Life, CFB to END OF TREATMENT
|
—
|
-6.67 Scores on scale
Standard Deviation 27.889
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Cond Interfere Social Activity, CFB to CYCLE 2 DAY 1
|
9.09 Scores on scale
Standard Deviation 30.151
|
9.09 Scores on scale
Standard Deviation 33.635
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Cond Interfere Social Activity, CFB to CYCLE 3 DAY 1
|
13.89 Scores on scale
Standard Deviation 30.011
|
11.11 Scores on scale
Standard Deviation 28.868
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Cond Interfere Social Activity, CFB to Pre-IDS EVALUATION
|
0.00 Scores on scale
Standard Deviation 26.149
|
22.22 Scores on scale
Standard Deviation 17.213
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Cond Interfere Social Activity, CFB to END OF TREATMENT
|
—
|
13.33 Scores on scale
Standard Deviation 18.257
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Dyspnea Symptom Scale, CFB to CYCLE 2 DAY 1
|
-3.03 Scores on scale
Standard Deviation 10.050
|
3.03 Scores on scale
Standard Deviation 17.979
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Dyspnea Symptom Scale, CFB to CYCLE 3 DAY 1
|
0.00 Scores on scale
Standard Deviation 14.213
|
0.00 Scores on scale
Standard Deviation 28.868
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Dyspnea Symptom Scale, CFB to Pre-IDS EVALUATION
|
0.00 Scores on scale
Standard Deviation 13.074
|
0.00 Scores on scale
Standard Deviation 47.140
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Dyspnea Symptom Scale, CFB to END OF TREATMENT
|
—
|
6.67 Scores on scale
Standard Deviation 27.889
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Were You Short of Breath, CFB to CYCLE 2 DAY 1
|
-3.03 Scores on scale
Standard Deviation 10.050
|
3.03 Scores on scale
Standard Deviation 17.979
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Were You Short of Breath, CFB to CYCLE 3 DAY 1
|
0.00 Scores on scale
Standard Deviation 14.213
|
0.00 Scores on scale
Standard Deviation 28.868
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Were You Short of Breath, CFB to Pre-IDS EVALUATION
|
0.00 Scores on scale
Standard Deviation 13.074
|
0.00 Scores on scale
Standard Deviation 47.140
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Were You Short of Breath, CFB to END OF TREATMENT
|
—
|
6.67 Scores on scale
Standard Deviation 27.889
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Global Health Status/QoL, CFB to CYCLE 2 DAY 1
|
0.00 Scores on scale
Standard Deviation 19.365
|
3.79 Scores on scale
Standard Deviation 27.224
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Global Health Status/QoL, CFB to CYCLE 3 DAY 1
|
7.64 Scores on scale
Standard Deviation 16.460
|
10.19 Scores on scale
Standard Deviation 38.814
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Global Health Status/QoL, CFB to Pre-IDS EVALUATION
|
-4.17 Scores on scale
Standard Deviation 22.349
|
9.72 Scores on scale
Standard Deviation 27.597
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Global Health Status/QoL, CFB to END OF TREATMENT
|
—
|
-23.33 Scores on scale
Standard Deviation 23.863
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Rate Your Overall Health, CFB to CYCLE 2 DAY 1
|
-1.52 Scores on scale
Standard Deviation 22.918
|
4.55 Scores on scale
Standard Deviation 27.979
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Rate Your Overall Health, CFB to CYCLE 3 DAY 1
|
9.72 Scores on scale
Standard Deviation 16.603
|
9.26 Scores on scale
Standard Deviation 40.062
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Rate Your Overall Health, CFB to Pre-IDS EVALUATION
|
-4.76 Scores on scale
Standard Deviation 23.956
|
11.11 Scores on scale
Standard Deviation 29.187
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Rate Your Overall Health, CFB to END OF TREATMENT
|
—
|
-20.00 Scores on scale
Standard Deviation 18.257
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Rate Your Overall Quality of Life, CFB to CYCLE 2 DAY 1
|
1.52 Scores on scale
Standard Deviation 18.936
|
3.03 Scores on scale
Standard Deviation 28.692
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Rate Your Overall Quality of Life, CFB to CYCLE 3 DAY 1
|
5.56 Scores on scale
Standard Deviation 19.245
|
11.11 Scores on scale
Standard Deviation 38.188
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Rate Your Overall Quality of Life, CFB to Pre-IDS EVALUATION
|
-3.57 Scores on scale
Standard Deviation 21.857
|
8.33 Scores on scale
Standard Deviation 27.386
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Rate Your Overall Quality of Life, CFB to END OF TREATMENT
|
—
|
-26.67 Scores on scale
Standard Deviation 32.489
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Physical Functioning Scale, CFB to CYCLE 2 DAY 1
|
0.61 Scores on scale
Standard Deviation 13.150
|
7.27 Scores on scale
Standard Deviation 12.808
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Physical Functioning Scale, CFB to CYCLE 3 DAY 1
|
1.53 Scores on scale
Standard Deviation 12.702
|
10.37 Scores on scale
Standard Deviation 16.025
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Physical Functioning Scale, CFB to Pre-IDS EVALUATION
|
-1.43 Scores on scale
Standard Deviation 10.838
|
14.44 Scores on scale
Standard Deviation 20.403
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Physical Functioning Scale, CFB to END OF TREATMENT
|
—
|
-9.33 Scores on scale
Standard Deviation 17.385
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Trouble Doing Strenuous Activity, CFB to CYCLE 2 DAY 1
|
0.00 Scores on scale
Standard Deviation 21.082
|
3.03 Scores on scale
Standard Deviation 27.707
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Trouble Doing Strenuous Activity, CFB to CYCLE 3 DAY 1
|
-2.78 Scores on scale
Standard Deviation 9.623
|
22.22 Scores on scale
Standard Deviation 23.570
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Trouble Doing Strenuous Activity, CFB to Pre-IDS EVALUATION
|
-7.14 Scores on scale
Standard Deviation 19.298
|
22.22 Scores on scale
Standard Deviation 34.427
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Trouble Doing Strenuous Activity, CFB to END OF TREATMENT
|
—
|
0.00 Scores on scale
Standard Deviation 33.333
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Have Trouble Taking a Long Walk, CFB to CYCLE 2 DAY 1
|
0.00 Scores on scale
Standard Deviation 21.082
|
21.21 Scores on scale
Standard Deviation 30.814
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Have Trouble Taking a Long Walk, CFB to CYCLE 3 DAY 1
|
13.89 Scores on scale
Standard Deviation 30.011
|
11.11 Scores on scale
Standard Deviation 28.868
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Have Trouble Taking a Long Walk, CFB to Pre-IDS EVALUATION
|
4.76 Scores on scale
Standard Deviation 22.100
|
22.22 Scores on scale
Standard Deviation 34.427
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Have Trouble Taking a Long Walk, CFB to END OF TREATMENT
|
—
|
-6.67 Scores on scale
Standard Deviation 14.907
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Have Trouble Taking Short Walk, CFB to CYCLE 2 DAY 1
|
6.06 Scores on scale
Standard Deviation 20.101
|
9.09 Scores on scale
Standard Deviation 15.570
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Have Trouble Taking Short Walk, CFB to CYCLE 3 DAY 1
|
0.00 Scores on scale
Standard Deviation 33.333
|
7.41 Scores on scale
Standard Deviation 14.699
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Have Trouble Taking Short Walk, CFB to Pre-IDS EVALUATION
|
-4.76 Scores on scale
Standard Deviation 17.817
|
16.67 Scores on scale
Standard Deviation 27.889
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Have Trouble Taking Short Walk, CFB to END OF TREATMENT
|
—
|
-13.33 Scores on scale
Standard Deviation 18.257
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Stay in Bed or Chair During Day, CFB to CYCLE 2 DAY 1
|
-3.03 Scores on scale
Standard Deviation 17.979
|
0.00 Scores on scale
Standard Deviation 25.820
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Stay in Bed or Chair During Day, CFB to CYCLE 3 DAY 1
|
-2.78 Scores on scale
Standard Deviation 22.285
|
7.41 Scores on scale
Standard Deviation 22.222
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Stay in Bed or Chair During Day, CFB to Pre-IDS EVALUATION
|
0.00 Scores on scale
Standard Deviation 18.490
|
0.00 Scores on scale
Standard Deviation 21.082
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Stay in Bed or Chair During Day, CFB to END OF TREATMENT
|
—
|
-13.33 Scores on scale
Standard Deviation 18.257
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Need Help Eating Dressing Washing, CFB to CYCLE 2 DAY 1
|
0.00 Scores on scale
Standard Deviation 0.000
|
3.03 Scores on scale
Standard Deviation 17.979
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Need Help Eating Dressing Washing, CFB to CYCLE 3 DAY 1
|
0.00 Scores on scale
Standard Deviation 0.000
|
3.70 Scores on scale
Standard Deviation 20.031
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Need Help Eating Dressing Washing, CFB to Pre-IDS EVALUATION
|
0.00 Scores on scale
Standard Deviation 0.000
|
11.11 Scores on scale
Standard Deviation 17.213
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire
Need Help Eating Dressing Washing, CFB to END OF TREATMENT
|
—
|
-13.33 Scores on scale
Standard Deviation 18.257
|
SECONDARY outcome
Timeframe: Baseline (Predose), Day 1 of Cycle 2 and Cycle 3; Pre-IDS Evaluation, and End of Treatment (Up to approximately 154 weeks).Population: Intent to Treat Population is included as the Overall Number of Participants Analyzed. 'Number Analyzed' refers to participants evaluable at the specified time points. The "0" participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups.
The OC module (QLQ-OV28) supplements the QLQ-C30 and was designed for participants with local or advanced disease who receive treatment by surgery with or without chemotherapy. It consists of 28 items including 3 functional scales (body image, sexuality, attitude to disease/treatment burden) and 5 symptom scales/items (abdominal/gastrointestinal symptoms, peripheral neuropathy, hormonal/menopausal symptoms, other chemotherapy side effects, and hair loss). A subset of 9 questions will be utilized for this cohort, referred to as the EORTC IL137. The scoring approach is identical to the EORTC QLQ-C30. Scores are transformed to a 0-100 scale, where higher functional scale scores indicate better functioning, and higher symptom scale scores indicate greater symptom burden. Baseline is defined as the latest assessment with a non-missing value prior to C1D1, including unscheduled visits.
Outcome measures
| Measure |
Platinum-taxane
n=17 Participants
Participants with ovarian cancer received platinum-taxane doublet chemotherapy as solution for intravenous infusion for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent interval debulking surgery (IDS) with recovery period of up to 6 weeks. After IDS, all participants received another three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional followed by niraparib maintenance treatment for up to 36 months or until an adverse event (AE), progression of disease (PD) per RECIST v1.1.
|
Niraparib
n=19 Participants
Participants with ovarian cancer received 100 milligram (mg) Niraparib capsules orally for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent IDS with recovery period of up to 6 weeks. After IDS, all participants received three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional, followed by niraparib maintenance treatment for up to 36 months or until an AE, PD per RECIST v1.1. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelets count ≥ 150000 cells per microliter were administered 300 mg of Niraparib. Participants with screening actual body weight less than 77 kg or screening platelets count less than 150000 cells per microliter were administered 200 mg of niraparib.
|
|---|---|---|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Felt physically Less Attractive, CFB to END OF TREATMENT
|
—
|
13.33 Scores on scale
Standard Deviation 38.006
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Disease Burden, CFB to CYCLE 2 DAY 1
|
5.56 Scores on scale
Standard Deviation 19.245
|
10.00 Scores on scale
Standard Deviation 27.442
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Disease Burden, CFB to CYCLE 3 DAY 1
|
11.11 Scores on scale
Standard Deviation 25.950
|
14.81 Scores on scale
Standard Deviation 50.308
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Disease Burden, CFB to Pre-IDS EVALUATION
|
11.90 Scores on scale
Standard Deviation 24.832
|
0.00 Scores on scale
Standard Deviation 42.164
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Disease Burden, CFB to END OF TREATMENT
|
—
|
13.33 Scores on scale
Standard Deviation 44.721
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Treatment Burden, CFB to CYCLE 2 DAY 1
|
-8.33 Scores on scale
Standard Deviation 32.177
|
3.33 Scores on scale
Standard Deviation 39.907
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Treatment Burden, CFB to CYCLE 3 DAY 1
|
0.00 Scores on scale
Standard Deviation 24.618
|
7.41 Scores on scale
Standard Deviation 32.394
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Treatment Burden, CFB to Pre-IDS EVALUATION
|
2.38 Scores on scale
Standard Deviation 27.625
|
11.11 Scores on scale
Standard Deviation 27.217
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Treatment Burden, CFB to END OF TREATMENT
|
—
|
13.33 Scores on scale
Standard Deviation 18.257
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Bloated Feeling Abdomen, CFB to CYCLE 2 DAY 1
|
-8.33 Scores on scale
Standard Deviation 35.176
|
-10.00 Scores on scale
Standard Deviation 41.722
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Bloated Feeling Abdomen, CFB to CYCLE 3 DAY 1
|
0.00 Scores on scale
Standard Deviation 42.640
|
-14.81 Scores on scale
Standard Deviation 29.397
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Bloated Feeling Abdomen, CFB to Pre-IDS EVALUATION
|
0.00 Scores on scale
Standard Deviation 29.235
|
-5.56 Scores on scale
Standard Deviation 49.065
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Bloated Feeling Abdomen, CFB to END OF TREATMENT
|
—
|
6.67 Scores on scale
Standard Deviation 43.461
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Change Bowel Habit, CFB to CYCLE 2 DAY 1
|
-33.33 Scores on scale
Standard Deviation 34.816
|
0.00 Scores on scale
Standard Deviation 41.574
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Change Bowel Habit, CFB to CYCLE 3 DAY 1
|
-13.89 Scores on scale
Standard Deviation 45.965
|
-7.41 Scores on scale
Standard Deviation 22.222
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Change Bowel Habit, CFB to Pre-IDS EVALUATION
|
-16.67 Scores on scale
Standard Deviation 31.351
|
-11.11 Scores on scale
Standard Deviation 40.369
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Change Bowel Habit, CFB to END OF TREATMENT
|
—
|
-6.67 Scores on scale
Standard Deviation 14.907
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Troubled Pass Flatulence, CFB to CYCLE 2 DAY 1
|
8.33 Scores on scale
Standard Deviation 25.126
|
-3.33 Scores on scale
Standard Deviation 24.595
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Troubled Pass Flatulence, CFB to CYCLE 3 DAY 1
|
-2.78 Scores on scale
Standard Deviation 22.285
|
-3.70 Scores on scale
Standard Deviation 35.136
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Troubled Pass Flatulence, CFB to Pre-IDS EVALUATION
|
7.14 Scores on scale
Standard Deviation 26.726
|
0.00 Scores on scale
Standard Deviation 29.814
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Troubled Pass Flatulence, CFB to END OF TREATMENT
|
—
|
-20.00 Scores on scale
Standard Deviation 29.814
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Felt Full Quick after Begin Eat, CFB to CYCLE 2 DAY 1
|
-13.89 Scores on scale
Standard Deviation 22.285
|
0.00 Scores on scale
Standard Deviation 41.574
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Felt Full Quick after Begin Eat, CFB to CYCLE 3 DAY 1
|
-15.15 Scores on scale
Standard Deviation 22.918
|
-14.81 Scores on scale
Standard Deviation 33.793
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Felt Full Quick after Begin Eat, CFB to Pre-IDS EVALUATION
|
-11.90 Scores on scale
Standard Deviation 28.063
|
5.56 Scores on scale
Standard Deviation 25.092
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Felt Full Quick after Begin Eat, CFB to END OF TREATMENT
|
—
|
-6.67 Scores on scale
Standard Deviation 59.628
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Acid Indigestion or Heartburn, CFB to CYCLE 2 DAY 1
|
2.78 Scores on scale
Standard Deviation 17.164
|
-3.33 Scores on scale
Standard Deviation 29.187
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Acid Indigestion or Heartburn, CFB to CYCLE 3 DAY 1
|
5.56 Scores on scale
Standard Deviation 12.975
|
-7.41 Scores on scale
Standard Deviation 32.394
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Acid Indigestion or Heartburn, CFB to Pre-IDS EVALUATION
|
7.14 Scores on scale
Standard Deviation 14.194
|
-11.11 Scores on scale
Standard Deviation 27.217
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Acid Indigestion or Heartburn, CFB to END OF TREATMENT
|
—
|
6.67 Scores on scale
Standard Deviation 27.889
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Felt Weak in Your Arms or Legs, CFB to CYCLE 2 DAY 1
|
-5.56 Scores on scale
Standard Deviation 19.245
|
-6.67 Scores on scale
Standard Deviation 21.082
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Felt Weak in Your Arms or Legs, CFB to CYCLE 3 DAY 1
|
18.18 Scores on scale
Standard Deviation 34.524
|
-18.52 Scores on scale
Standard Deviation 33.793
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Felt Weak in Your Arms or Legs, CFB to Pre-IDS EVALUATION
|
4.76 Scores on scale
Standard Deviation 34.237
|
-11.11 Scores on scale
Standard Deviation 34.427
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Felt Weak in Your Arms or Legs, CFB to END OF TREATMENT
|
—
|
6.67 Scores on scale
Standard Deviation 27.889
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Felt physically Less Attractive, CFB to CYCLE 2 DAY 1
|
-2.78 Scores on scale
Standard Deviation 17.164
|
-3.33 Scores on scale
Standard Deviation 33.148
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Felt physically Less Attractive, CFB to CYCLE 3 DAY 1
|
-2.78 Scores on scale
Standard Deviation 33.207
|
7.41 Scores on scale
Standard Deviation 52.116
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire
Felt physically Less Attractive, CFB to Pre-IDS EVALUATION
|
0.00 Scores on scale
Standard Deviation 18.490
|
-16.67 Scores on scale
Standard Deviation 27.889
|
SECONDARY outcome
Timeframe: Up to approximately 154 weeksPopulation: Safety population included all randomized participants who received at least one dose of study treatment.
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, is life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, is a congenital anomaly/birth defect, other situations and is associated with liver injury or impaired liver function. SAEs are subsets of AEs. TEAE is an event that emerged during treatment having been absent pretreatment or worsened relative to the pretreatment state. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Outcome measures
| Measure |
Platinum-taxane
n=17 Participants
Participants with ovarian cancer received platinum-taxane doublet chemotherapy as solution for intravenous infusion for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent interval debulking surgery (IDS) with recovery period of up to 6 weeks. After IDS, all participants received another three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional followed by niraparib maintenance treatment for up to 36 months or until an adverse event (AE), progression of disease (PD) per RECIST v1.1.
|
Niraparib
n=19 Participants
Participants with ovarian cancer received 100 milligram (mg) Niraparib capsules orally for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent IDS with recovery period of up to 6 weeks. After IDS, all participants received three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional, followed by niraparib maintenance treatment for up to 36 months or until an AE, PD per RECIST v1.1. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelets count ≥ 150000 cells per microliter were administered 300 mg of Niraparib. Participants with screening actual body weight less than 77 kg or screening platelets count less than 150000 cells per microliter were administered 200 mg of niraparib.
|
|---|---|---|
|
Number of Participants With Treatment Emergent (TE) Non-serious Adverse Events (Non-SAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Treatment Emergent (TE) Special Interest (AESIs) by Severity
TE Non-SAEs
|
17 Participants
|
19 Participants
|
|
Number of Participants With Treatment Emergent (TE) Non-serious Adverse Events (Non-SAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Treatment Emergent (TE) Special Interest (AESIs) by Severity
TESAEs
|
4 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent (TE) Non-serious Adverse Events (Non-SAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Treatment Emergent (TE) Special Interest (AESIs) by Severity
TE AESIs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 154 weeksPopulation: Safety population
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is an event that emerged during treatment having been absent pretreatment or worsened relative to the pretreatment state. Number of participants with dose modifications : permanent discontinuation, dose reduction and treatment interruption/delay due to AEs is summarized.
Outcome measures
| Measure |
Platinum-taxane
n=17 Participants
Participants with ovarian cancer received platinum-taxane doublet chemotherapy as solution for intravenous infusion for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent interval debulking surgery (IDS) with recovery period of up to 6 weeks. After IDS, all participants received another three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional followed by niraparib maintenance treatment for up to 36 months or until an adverse event (AE), progression of disease (PD) per RECIST v1.1.
|
Niraparib
n=19 Participants
Participants with ovarian cancer received 100 milligram (mg) Niraparib capsules orally for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent IDS with recovery period of up to 6 weeks. After IDS, all participants received three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional, followed by niraparib maintenance treatment for up to 36 months or until an AE, PD per RECIST v1.1. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelets count ≥ 150000 cells per microliter were administered 300 mg of Niraparib. Participants with screening actual body weight less than 77 kg or screening platelets count less than 150000 cells per microliter were administered 200 mg of niraparib.
|
|---|---|---|
|
Number of Participants With Dose Modification Due to TEAEs
Permanent Discontinuation
|
5 Participants
|
4 Participants
|
|
Number of Participants With Dose Modification Due to TEAEs
Dose Reduction
|
14 Participants
|
7 Participants
|
|
Number of Participants With Dose Modification Due to TEAEs
Treatment Interruption/delay
|
11 Participants
|
11 Participants
|
Adverse Events
Platinum-taxane
Serious events: 4 serious events
Other events: 17 other events
Deaths: 4 deaths
Niraparib
Serious events: 2 serious events
Other events: 19 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Platinum-taxane
n=17 participants at risk
Participants with ovarian cancer received platinum-taxane doublet chemotherapy as solution for intravenous infusion for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent interval debulking surgery (IDS) with recovery period of up to 6 weeks. After IDS, all participants received another three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional followed by niraparib maintenance treatment for up to 36 months or until an adverse event (AE), progression of disease (PD) per RECIST v1.1.
|
Niraparib
n=19 participants at risk
Participants with ovarian cancer received 100 milligram (mg) Niraparib capsules orally for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent IDS with recovery period of up to 6 weeks. After IDS, all participants received three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional, followed by niraparib maintenance treatment for up to 36 months or until an AE, PD per RECIST v1.1. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelets count ≥ 150000 cells per microliter were administered 300 mg of Niraparib. Participants with screening actual body weight less than 77 kg or screening platelets count less than 150000 cells per microliter were administered 200 mg of niraparib.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardiac failure
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
11.8%
2/17 • Number of events 3 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Large intestine perforation
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
General disorders
General physical health deterioration
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Pelvic haematoma
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypotension
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
Platinum-taxane
n=17 participants at risk
Participants with ovarian cancer received platinum-taxane doublet chemotherapy as solution for intravenous infusion for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent interval debulking surgery (IDS) with recovery period of up to 6 weeks. After IDS, all participants received another three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional followed by niraparib maintenance treatment for up to 36 months or until an adverse event (AE), progression of disease (PD) per RECIST v1.1.
|
Niraparib
n=19 participants at risk
Participants with ovarian cancer received 100 milligram (mg) Niraparib capsules orally for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent IDS with recovery period of up to 6 weeks. After IDS, all participants received three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional, followed by niraparib maintenance treatment for up to 36 months or until an AE, PD per RECIST v1.1. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelets count ≥ 150000 cells per microliter were administered 300 mg of Niraparib. Participants with screening actual body weight less than 77 kg or screening platelets count less than 150000 cells per microliter were administered 200 mg of niraparib.
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
47.1%
8/17 • Number of events 20 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
26.3%
5/19 • Number of events 13 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
64.7%
11/17 • Number of events 40 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
52.6%
10/19 • Number of events 24 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.9%
1/17 • Number of events 5 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
47.1%
8/17 • Number of events 16 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
15.8%
3/19 • Number of events 9 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardiac failure
|
5.9%
1/17 • Number of events 4 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Palpitations
|
17.6%
3/17 • Number of events 4 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Tachycardia
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Hypoacusis
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
17.6%
3/17 • Number of events 3 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Thyroiditis
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Eye disorders
Cataract
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Eye disorders
Diplopia
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Eye disorders
Eczema eyelids
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Eye disorders
Eye swelling
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Eye disorders
Narrow anterior chamber angle
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Eye disorders
Vision blurred
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
15.8%
3/19 • Number of events 3 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal hernia
|
11.8%
2/17 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
47.1%
8/17 • Number of events 16 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
31.6%
6/19 • Number of events 9 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
10.5%
2/19 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal wall pain
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Anal fissure
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Ascites
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Colitis
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
58.8%
10/17 • Number of events 14 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
42.1%
8/19 • Number of events 13 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dental caries
|
11.8%
2/17 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
29.4%
5/17 • Number of events 9 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
15.8%
3/19 • Number of events 4 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
11.8%
2/17 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.8%
2/17 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Eructation
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
5.9%
1/17 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Food poisoning
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
29.4%
5/17 • Number of events 7 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gingival bleeding
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
17.6%
3/17 • Number of events 5 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
5.9%
1/17 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
64.7%
11/17 • Number of events 25 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
21.1%
4/19 • Number of events 5 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Peritoneal haematoma
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
11.8%
2/17 • Number of events 4 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
11.8%
2/17 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
10.5%
2/19 • Number of events 3 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
47.1%
8/17 • Number of events 14 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
21.1%
4/19 • Number of events 7 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Asthenia
|
23.5%
4/17 • Number of events 10 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
21.1%
4/19 • Number of events 6 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Early satiety
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
82.4%
14/17 • Number of events 46 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
36.8%
7/19 • Number of events 12 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
General disorders
General physical health deterioration
|
5.9%
1/17 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Generalised oedema
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Influenza like illness
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
15.8%
3/19 • Number of events 4 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Non-cardiac chest pain
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Oedema
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Oedema peripheral
|
5.9%
1/17 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Pain
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
17.6%
3/17 • Number of events 5 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Immune system disorders
Drug hypersensitivity
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bacterial vaginosis
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
COVID-19
|
17.6%
3/17 • Number of events 3 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Cellulitis
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Ear infection
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Folliculitis
|
5.9%
1/17 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Herpes ophthalmic
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
35.3%
6/17 • Number of events 9 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Oral candidiasis
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Oral herpes
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Otitis externa
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Peritonitis
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Postoperative abscess
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Rash pustular
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
10.5%
2/19 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
23.5%
4/17 • Number of events 4 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
17.6%
3/17 • Number of events 4 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Gastrointestinal procedural complication
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
11.8%
2/17 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Post procedural constipation
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Postoperative adhesion
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
15.8%
3/19 • Number of events 3 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
11.8%
2/17 • Number of events 3 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
15.8%
3/19 • Number of events 5 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
5.9%
1/17 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
11.8%
2/17 • Number of events 4 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
17.6%
3/17 • Number of events 3 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Blood creatinine increased
|
17.6%
3/17 • Number of events 3 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
10.5%
2/19 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Blood pressure increased
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Brain natriuretic peptide increased
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Neutrophil count decreased
|
35.3%
6/17 • Number of events 17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
21.1%
4/19 • Number of events 8 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Oxygen saturation decreased
|
5.9%
1/17 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Platelet count decreased
|
35.3%
6/17 • Number of events 10 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 3 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Weight decreased
|
11.8%
2/17 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Weight increased
|
23.5%
4/17 • Number of events 8 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Investigations
White blood cell count decreased
|
11.8%
2/17 • Number of events 5 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
10.5%
2/19 • Number of events 3 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
35.3%
6/17 • Number of events 11 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
21.1%
4/19 • Number of events 4 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
23.5%
4/17 • Number of events 6 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
23.5%
4/17 • Number of events 5 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
15.8%
3/19 • Number of events 4 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
29.4%
5/17 • Number of events 11 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
15.8%
3/19 • Number of events 9 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.8%
2/17 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.9%
1/17 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
11.8%
2/17 • Number of events 3 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
11.8%
2/17 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
41.2%
7/17 • Number of events 11 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
15.8%
3/19 • Number of events 4 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
29.4%
5/17 • Number of events 6 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular pain and dysfunction syndrome
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Disturbance in attention
|
17.6%
3/17 • Number of events 3 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
35.3%
6/17 • Number of events 9 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
11.8%
2/17 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
15.8%
3/19 • Number of events 3 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
41.2%
7/17 • Number of events 18 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
21.1%
4/19 • Number of events 5 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Hyperaesthesia
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Memory impairment
|
11.8%
2/17 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Neuralgia
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
76.5%
13/17 • Number of events 34 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Paraesthesia
|
23.5%
4/17 • Number of events 9 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.9%
1/17 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Restless legs syndrome
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Speech disorder
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Tremor
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Pregnancy, puerperium and perinatal conditions
Umbilical granuloma
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
10.5%
2/19 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
47.1%
8/17 • Number of events 11 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
47.4%
9/19 • Number of events 9 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Haematuria
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Micturition urgency
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Breast haematoma
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Dyspareunia
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Pelvic haematoma
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
11.8%
2/17 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Vaginal haematoma
|
5.9%
1/17 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
17.6%
3/17 • Number of events 4 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.6%
3/17 • Number of events 3 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
23.5%
4/17 • Number of events 7 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
21.1%
4/19 • Number of events 6 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
17.6%
3/17 • Number of events 3 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.9%
1/17 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
5.9%
1/17 • Number of events 4 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
47.1%
8/17 • Number of events 12 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
15.8%
3/19 • Number of events 3 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
10.5%
2/19 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
11.8%
2/17 • Number of events 4 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Excessive granulation tissue
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail bed bleeding
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
11.8%
2/17 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
29.4%
5/17 • Number of events 11 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
41.2%
7/17 • Number of events 17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
15.8%
3/19 • Number of events 4 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Sensitive skin
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 2 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Vascular disorders
Haematoma
|
0.00%
0/17 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hot flush
|
17.6%
3/17 • Number of events 3 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
21.1%
4/19 • Number of events 4 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertension
|
29.4%
5/17 • Number of events 8 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
31.6%
6/19 • Number of events 11 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypotension
|
11.8%
2/17 • Number of events 5 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Vascular disorders
Varicose vein
|
5.9%
1/17 • Number of events 1 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/19 • All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Safety population included all randomized participants who received at least one dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER