Trial Outcomes & Findings for Ipilimumab With or Without High-Dose Recombinant Interferon Alfa-2b in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery (NCT NCT01708941)
NCT ID: NCT01708941
Last Updated: 2026-04-30
Results Overview
Progression-free survival (PFS) was defined as time from randomization to any documented disease progression or death from any cause, whichever occurred first (event), or censored at last date known alive.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
88 participants
Primary outcome timeframe
Assessed every 3 months for two years, then every 6 months for 3 years, then every 12 months for up to 10 years
Results posted on
2026-04-30
Participant Flow
Participants were recruited from ECOG-ACRIN member institutions between 1/18/2013 and 11/30/2015.
Participant milestones
| Measure |
Arm A (Higher Dose Ipilimumab, HDI)
INDUCTION PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks.
MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks.
Ipilimumab: Given IV
Recombinant Interferon Alfa-2b: Given IV or SC
|
Arm B (Higher Dose Ipilimumab)
INDUCTION PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses.
MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24.
Ipilimumab: Given IV
|
Arm C (Lower Dose Ipilimumab + HDI)
INDUCTION PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks.
MAINTENANCE PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks.
Ipilimumab: Given IV
Recombinant Interferon Alfa-2b: Given IV or SC
|
Arm D (Lower Dose Ipilimumab)
INDUCTION PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses.
MAINTENANCE PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24.
Ipilimumab: Given IV
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
23
|
22
|
22
|
|
Overall Study
Eligible and Started Treatment
|
18
|
22
|
19
|
22
|
|
Overall Study
COMPLETED
|
3
|
5
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
18
|
18
|
19
|
18
|
Reasons for withdrawal
| Measure |
Arm A (Higher Dose Ipilimumab, HDI)
INDUCTION PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks.
MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks.
Ipilimumab: Given IV
Recombinant Interferon Alfa-2b: Given IV or SC
|
Arm B (Higher Dose Ipilimumab)
INDUCTION PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses.
MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24.
Ipilimumab: Given IV
|
Arm C (Lower Dose Ipilimumab + HDI)
INDUCTION PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks.
MAINTENANCE PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks.
Ipilimumab: Given IV
Recombinant Interferon Alfa-2b: Given IV or SC
|
Arm D (Lower Dose Ipilimumab)
INDUCTION PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses.
MAINTENANCE PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24.
Ipilimumab: Given IV
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
6
|
1
|
0
|
|
Overall Study
Death
|
1
|
1
|
2
|
14
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
3
|
4
|
|
Overall Study
Disease progression
|
9
|
10
|
8
|
0
|
|
Overall Study
Alternative therapy
|
0
|
0
|
2
|
0
|
|
Overall Study
Ineligible and never started treatment
|
1
|
0
|
1
|
0
|
|
Overall Study
Never started treatment
|
2
|
1
|
0
|
0
|
|
Overall Study
Ineligible
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Ipilimumab With or Without High-Dose Recombinant Interferon Alfa-2b in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Arm A (Higher Dose Ipilimumab, HDI)
n=18 Participants
INDUCTION PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks.
MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks.
Ipilimumab: Given IV
Recombinant Interferon Alfa-2b: Given IV or SC
|
Arm B (Higher Dose Ipilimumab)
n=22 Participants
INDUCTION PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses.
MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24.
Ipilimumab: Given IV
|
Arm C (Lower Dose Ipilimumab + HDI)
n=19 Participants
INDUCTION PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks.
MAINTENANCE PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks.
Ipilimumab: Given IV
Recombinant Interferon Alfa-2b: Given IV or SC
|
Arm D (Lower Dose Ipilimumab)
n=22 Participants
INDUCTION PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses.
MAINTENANCE PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24.
Ipilimumab: Given IV
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60 years
n=14 Participants
|
57 years
n=34 Participants
|
65 years
n=69 Participants
|
57 years
n=140 Participants
|
58 years
n=451 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=14 Participants
|
8 Participants
n=34 Participants
|
6 Participants
n=69 Participants
|
9 Participants
n=140 Participants
|
33 Participants
n=451 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=14 Participants
|
14 Participants
n=34 Participants
|
13 Participants
n=69 Participants
|
13 Participants
n=140 Participants
|
48 Participants
n=451 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
2 Participants
n=451 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=14 Participants
|
22 Participants
n=34 Participants
|
18 Participants
n=69 Participants
|
22 Participants
n=140 Participants
|
78 Participants
n=451 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
1 Participants
n=451 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
1 Participants
n=140 Participants
|
1 Participants
n=451 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=14 Participants
|
22 Participants
n=34 Participants
|
18 Participants
n=69 Participants
|
21 Participants
n=140 Participants
|
79 Participants
n=451 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
1 Participants
n=451 Participants
|
PRIMARY outcome
Timeframe: Assessed every 3 months for two years, then every 6 months for 3 years, then every 12 months for up to 10 yearsPopulation: Assessed among eligible patients who started treatment. The primary objective of the study is to compare PFS on the combination of ipilimumab + HDI (Arms A \& C) versus ipilimumab alone (Arms B \& D), across ipilimumab treatment status. Thus data across arms are combined.
Progression-free survival (PFS) was defined as time from randomization to any documented disease progression or death from any cause, whichever occurred first (event), or censored at last date known alive.
Outcome measures
| Measure |
Ipilimumab + HDI
n=37 Participants
INDUCTION PHASE: Patients receive ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks.
MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks.
Ipilimumab: Given IV
Recombinant Interferon Alfa-2b: Given IV or SC
|
Ipilimumab Alone
n=44 Participants
INDUCTION PHASE: Patients receive ipilimumab IV over 90 minutes once every 3 weeks for 4 doses.
MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24.
Ipilimumab: Given IV
|
|---|---|---|
|
Progression-free Survival (PFS)
|
7.5 months
Interval 5.1 to 11.0
|
4.4 months
Interval 2.7 to 8.2
|
SECONDARY outcome
Timeframe: Assessed every 3 months for two years, then every 6 months for 3 years, then every 12 months for up to 10 yearsPopulation: Eligible patients who started treatment; PFS comparison of higher dose ipilimumab versus lower dose ipilimumab across HDI status (Arms A \& B versus Arms C \& D)
Progression-free survival (PFS) was defined as time from randomization to any documented disease progression or death from any cause, whichever occurred first (event), or censored at last date known alive.
Outcome measures
| Measure |
Ipilimumab + HDI
n=40 Participants
INDUCTION PHASE: Patients receive ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks.
MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks.
Ipilimumab: Given IV
Recombinant Interferon Alfa-2b: Given IV or SC
|
Ipilimumab Alone
n=41 Participants
INDUCTION PHASE: Patients receive ipilimumab IV over 90 minutes once every 3 weeks for 4 doses.
MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24.
Ipilimumab: Given IV
|
|---|---|---|
|
Progression-free Survival
|
6.5 months
Interval 5.1 to 13.5
|
3.8 months
Interval 2.6 to 7.5
|
SECONDARY outcome
Timeframe: Assessed every 3 months for two years, then every 6 months for 3 years, then every 12 months for up to 10 yearsPopulation: Eligible patients who started treatment; OS comparison of ipilimumab + HDI versus ipilimumab alone, across ipilimumab doses (Arms A \& C versus Arms B \& D)
Time from randomization to death (event), or censored at last date known alive
Outcome measures
| Measure |
Ipilimumab + HDI
n=37 Participants
INDUCTION PHASE: Patients receive ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks.
MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks.
Ipilimumab: Given IV
Recombinant Interferon Alfa-2b: Given IV or SC
|
Ipilimumab Alone
n=44 Participants
INDUCTION PHASE: Patients receive ipilimumab IV over 90 minutes once every 3 weeks for 4 doses.
MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24.
Ipilimumab: Given IV
|
|---|---|---|
|
Overall Survival (OS)
|
20.1 months
Interval 8.5 to 33.6
|
24.7 months
Interval 12.6 to 35.7
|
SECONDARY outcome
Timeframe: Assessed every 3 months for two years, then every 6 months for 3 years, then every 12 months for up to 10 yearsPopulation: Eligible patients who started treatment; OS comparison of higher dose ipilimumab versus lower dose ipilimumab across HDI status (Arms A \& B versus Arms C \& D)
Time from randomization to death (event), or censored at last date known alive.
Outcome measures
| Measure |
Ipilimumab + HDI
n=40 Participants
INDUCTION PHASE: Patients receive ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks.
MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks.
Ipilimumab: Given IV
Recombinant Interferon Alfa-2b: Given IV or SC
|
Ipilimumab Alone
n=41 Participants
INDUCTION PHASE: Patients receive ipilimumab IV over 90 minutes once every 3 weeks for 4 doses.
MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24.
Ipilimumab: Given IV
|
|---|---|---|
|
Overall Survival
|
20.1 months
Interval 10.4 to 31.4
|
23.5 months
Interval 11.7 to 35.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed every 12 weeks for 3 yearsDefined as the number of complete responses and partial responses per RECIST version 1.1 divided by the total number of evaluable cases
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed every 12 weeks for 3 yearsDefined as the number of complete and partial responses per immune-related response criteria (irRC) divided by the total number of evaluable patients
Outcome measures
Outcome data not reported
Adverse Events
Arm A (Higher Dose Ipilimumab, HDI)
Serious events: 17 serious events
Other events: 18 other events
Deaths: 11 deaths
Arm B (Higher Dose Ipilimumab)
Serious events: 12 serious events
Other events: 21 other events
Deaths: 13 deaths
Arm C (Lower Dose Ipilimumab + HDI)
Serious events: 16 serious events
Other events: 20 other events
Deaths: 14 deaths
Arm D (Lower Dose Ipilimumab)
Serious events: 10 serious events
Other events: 20 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Arm A (Higher Dose Ipilimumab, HDI)
n=18 participants at risk
INDUCTION PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks.
MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks.
Ipilimumab: Given IV
Recombinant Interferon Alfa-2b: Given IV or SC
|
Arm B (Higher Dose Ipilimumab)
n=22 participants at risk
INDUCTION PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses.
MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24.
Ipilimumab: Given IV
|
Arm C (Lower Dose Ipilimumab + HDI)
n=21 participants at risk
INDUCTION PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks.
MAINTENANCE PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks.
Ipilimumab: Given IV
Recombinant Interferon Alfa-2b: Given IV or SC
|
Arm D (Lower Dose Ipilimumab)
n=22 participants at risk
INDUCTION PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses.
MAINTENANCE PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24.
Ipilimumab: Given IV
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
3/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
General disorders
Chills
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
General disorders
Fatigue
|
50.0%
9/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.1%
2/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
38.1%
8/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
General disorders
Flu like symptoms
|
11.1%
2/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
General disorders
Pain
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.1%
2/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Endocrine disorders
Adrenal insufficiency
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.1%
2/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Gastrointestinal disorders
Nausea
|
27.8%
5/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Gastrointestinal disorders
Pancreatitis
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Infections and infestations
Encephalitis infection
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Infections and infestations
Lung infection
|
16.7%
3/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
2/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.1%
2/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
3/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.1%
2/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
19.0%
4/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Investigations
CPK increased
|
11.1%
2/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Investigations
Lipase increased
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.1%
2/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.1%
2/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Investigations
Lymphocyte count decreased
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.5%
2/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Investigations
Neutrophil count decreased
|
22.2%
4/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
14.3%
3/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Investigations
Platelet count decreased
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Investigations
Serum amylase increased
|
11.1%
2/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Investigations
Weight loss
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Investigations
White blood cell decreased
|
16.7%
3/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Metabolism and nutrition disorders
Anorexia
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.1%
2/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.1%
2/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.5%
2/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.1%
2/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.5%
2/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Nervous system disorders
Syncope
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Eye disorders
Uveitis
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Psychiatric disorders
Confusion
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Psychiatric disorders
Insomnia
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Psychiatric disorders
Suicide attempt
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Vascular disorders
Hypertension
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Vascular disorders
Hypotension
|
11.1%
2/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
Other adverse events
| Measure |
Arm A (Higher Dose Ipilimumab, HDI)
n=18 participants at risk
INDUCTION PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks.
MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks.
Ipilimumab: Given IV
Recombinant Interferon Alfa-2b: Given IV or SC
|
Arm B (Higher Dose Ipilimumab)
n=22 participants at risk
INDUCTION PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses.
MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24.
Ipilimumab: Given IV
|
Arm C (Lower Dose Ipilimumab + HDI)
n=21 participants at risk
INDUCTION PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks.
MAINTENANCE PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks.
Ipilimumab: Given IV
Recombinant Interferon Alfa-2b: Given IV or SC
|
Arm D (Lower Dose Ipilimumab)
n=22 participants at risk
INDUCTION PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses.
MAINTENANCE PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24.
Ipilimumab: Given IV
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.1%
2/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Blood and lymphatic system disorders
Anemia
|
55.6%
10/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
47.6%
10/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.1%
2/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Cardiac disorders
Sinus tachycardia
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
General disorders
Chills
|
44.4%
8/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.1%
2/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
61.9%
13/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
General disorders
Edema limbs
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
General disorders
Fatigue
|
88.9%
16/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
63.6%
14/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
81.0%
17/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
54.5%
12/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
General disorders
Fever
|
61.1%
11/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
13.6%
3/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
66.7%
14/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
General disorders
Flu like symptoms
|
11.1%
2/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.5%
2/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
General disorders
Infusion related reaction
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
General disorders
Injection site reaction
|
11.1%
2/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
General disorders
Localized edema
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
General disorders
Malaise
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
General disorders
Pain
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.1%
2/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
72.2%
13/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
63.6%
14/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
33.3%
7/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
54.5%
12/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
83.3%
15/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
63.6%
14/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
28.6%
6/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
50.0%
11/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
11.1%
2/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.1%
2/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Endocrine disorders
Adrenal insufficiency
|
11.1%
2/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
13.6%
3/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Endocrine disorders
Hypothyroidism
|
27.8%
5/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.1%
2/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.5%
2/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
13.6%
3/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
33.3%
6/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
18.2%
4/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
28.6%
6/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
18.2%
4/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Gastrointestinal disorders
Abdominal pain
|
22.2%
4/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
22.7%
5/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.5%
2/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.1%
2/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Gastrointestinal disorders
Colitis
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
3/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
19.0%
4/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
13.6%
3/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Gastrointestinal disorders
Diarrhea
|
61.1%
11/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
31.8%
7/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
33.3%
7/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
36.4%
8/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Gastrointestinal disorders
Dry mouth
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.5%
2/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Gastrointestinal disorders
Mucositis oral
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.5%
2/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Gastrointestinal disorders
Nausea
|
72.2%
13/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
18.2%
4/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
42.9%
9/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
31.8%
7/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Gastrointestinal disorders
Vomiting
|
61.1%
11/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
18.2%
4/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
14.3%
3/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
13.6%
3/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Infections and infestations
Skin infection
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Investigations
Alanine aminotransferase increased
|
38.9%
7/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
18.2%
4/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
57.1%
12/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.1%
2/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Investigations
Alkaline phosphatase increased
|
27.8%
5/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.1%
2/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
28.6%
6/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
22.7%
5/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Investigations
Aspartate aminotransferase increased
|
77.8%
14/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
13.6%
3/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
61.9%
13/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.1%
2/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Investigations
Blood bilirubin increased
|
11.1%
2/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.5%
2/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Investigations
Blood corticotrophin decreased
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Investigations
CPK increased
|
22.2%
4/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
14.3%
3/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Investigations
Creatinine increased
|
11.1%
2/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Investigations
GGT increased
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Investigations
Lipase increased
|
44.4%
8/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
13.6%
3/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
14.3%
3/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
13.6%
3/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
6/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
19.0%
4/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Investigations
Lymphocyte count increased
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Investigations
Neutrophil count decreased
|
50.0%
9/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.1%
2/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
42.9%
9/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Investigations
Platelet count decreased
|
38.9%
7/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
42.9%
9/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Investigations
Serum amylase increased
|
22.2%
4/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
18.2%
4/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
28.6%
6/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
13.6%
3/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Investigations
Weight loss
|
38.9%
7/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
13.6%
3/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
28.6%
6/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.1%
2/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Investigations
White blood cell decreased
|
61.1%
11/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
47.6%
10/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Investigations
Investigations - Other, specify
|
16.7%
3/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
27.3%
6/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
28.6%
6/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
18.2%
4/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Metabolism and nutrition disorders
Anorexia
|
77.8%
14/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
22.7%
5/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
61.9%
13/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
13.6%
3/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Metabolism and nutrition disorders
Dehydration
|
27.8%
5/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.5%
2/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.1%
2/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.5%
2/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.1%
2/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
6/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
33.3%
7/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
3/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
14.3%
3/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
14.3%
3/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
3/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.1%
2/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
19.0%
4/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.1%
2/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
38.9%
7/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
23.8%
5/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
3/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
22.7%
5/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
19.0%
4/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
22.2%
4/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.5%
2/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.1%
2/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
6/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
13.6%
3/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
28.6%
6/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
13.6%
3/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.5%
2/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Nervous system disorders
Dizziness
|
38.9%
7/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
14.3%
3/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Nervous system disorders
Dysgeusia
|
27.8%
5/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
38.1%
8/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Nervous system disorders
Headache
|
22.2%
4/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
18.2%
4/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
19.0%
4/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
31.8%
7/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Nervous system disorders
Paresthesia
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.5%
2/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Eye disorders
Blurred vision
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.1%
2/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Eye disorders
Eye disorders - Other, specify
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Psychiatric disorders
Anxiety
|
11.1%
2/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
14.3%
3/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.5%
2/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Psychiatric disorders
Depression
|
16.7%
3/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
19.0%
4/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Psychiatric disorders
Insomnia
|
16.7%
3/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.1%
2/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
14.3%
3/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Psychiatric disorders
Restlessness
|
11.1%
2/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.1%
2/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.8%
1/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
2/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.5%
2/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.6%
1/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.1%
2/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Vascular disorders
Hypertension
|
0.00%
0/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
9.5%
2/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
4.5%
1/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
|
Vascular disorders
Hypotension
|
11.1%
2/18 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
19.0%
4/21 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
0.00%
0/22 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed in all patients who started treatment, regardless of eligibility. There were two ineligible patients on Arm C who began treatment who are included in this population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60