Trial Outcomes & Findings for Brentuximab Vedotin Before Autologous Stem Cell Transplant in Treating Patients With Hodgkin Lymphoma (NCT NCT01393717)
NCT ID: NCT01393717
Last Updated: 2018-04-26
Results Overview
The overall response rate is calculated as the percent of evaluable patients that have confirmed CR or PR by radiographic imaging, and the exact 95% confidence interval is calculated for this estimate. Per Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007) for target lesions and assessed by CT/PET scans: Complete Response (CR), complete disappearance of all detectable clinical and radiographic evidence of disease; Partial Response (PR), ≥50% decrease in the sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
21 days after completion of last course of study treatment, up to 5 years
Results posted on
2018-04-26
Participant Flow
Participant milestones
| Measure |
Cohort #1
Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses.
|
Cohort #2
Patients receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
20
|
|
Overall Study
COMPLETED
|
37
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brentuximab Vedotin Before Autologous Stem Cell Transplant in Treating Patients With Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
All Study Participants
n=57 Participants
Patients receive salvage brentuximab vedotin IV.
|
|---|---|
|
Age, Continuous
|
32 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
57 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 days after completion of last course of study treatment, up to 5 yearsPopulation: Among the 57 enrolled patients, only 56 patients were evaluable for efficacy.
The overall response rate is calculated as the percent of evaluable patients that have confirmed CR or PR by radiographic imaging, and the exact 95% confidence interval is calculated for this estimate. Per Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007) for target lesions and assessed by CT/PET scans: Complete Response (CR), complete disappearance of all detectable clinical and radiographic evidence of disease; Partial Response (PR), ≥50% decrease in the sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses.
Outcome measures
| Measure |
Patients Receive Brentuximab Vedotin
n=56 Participants
Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses. Patients in the new cohort receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
|
Cohort #2
Patients receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
|
|---|---|---|
|
Overall Response Rate Among Patients With Salvage Brentuximab Vedotin (BV)
|
75.0 percentage of participants with response
Interval 61.6 to 85.6
|
—
|
PRIMARY outcome
Timeframe: 21 days after completion of last course of study treatment, up to 5 yearsPopulation: Among the 57 enrolled patients, only 56 patients were evaluable for efficacy.
The CR rate is calculated as the percent of evaluable patients that have confirmed CR by radiographic imaging, and the exact 95% confidence interval is calculated for this estimate. Per Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007) for target lesions and assessed by CT/PET scans: Complete Response (CR), complete disappearance of all detectable clinical and radiographic evidence of disease.
Outcome measures
| Measure |
Patients Receive Brentuximab Vedotin
n=56 Participants
Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses. Patients in the new cohort receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
|
Cohort #2
Patients receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
|
|---|---|---|
|
Complete Response (CR) Rate Among Patients With Salvage Brentuximab Vedotin (BV)
|
42.9 percentage of participants with response
Interval 29.7 to 56.8
|
—
|
PRIMARY outcome
Timeframe: 21 days after completion of last course of study treatment, up to 5 yearsPopulation: Among the 20 enrolled patients in Cohort #2, all the 20 patients were evaluable for efficacy.
The overall response rate is calculated as the percent of evaluable patients that have confirmed CR or PR by radiographic imaging, and the exact 95% confidence interval is calculated for this estimate. Per Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007) for target lesions and assessed by CT/PET scans: Complete Response (CR), complete disappearance of all detectable clinical and radiographic evidence of disease; Partial Response (PR), ≥50% decrease in the sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses.
Outcome measures
| Measure |
Patients Receive Brentuximab Vedotin
n=20 Participants
Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses. Patients in the new cohort receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
|
Cohort #2
Patients receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
|
|---|---|---|
|
Overall Response Rate in Cohort #2
|
85.0 percentage of participants with response
Interval 62.1 to 96.8
|
—
|
PRIMARY outcome
Timeframe: 21 days after completion of last course of study treatment, up to 5 yearsPopulation: Among the 20 enrolled patients in Cohort #2, all the 20 patients were evaluable for efficacy.
The CR rate is calculated as the percent of evaluable patients that have confirmed CR by radiographic imaging, and the exact 95% confidence interval is calculated for this estimate. Per Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007) for target lesions and assessed by CT/PET scans: Complete Response (CR), complete disappearance of all detectable clinical and radiographic evidence of disease.
Outcome measures
| Measure |
Patients Receive Brentuximab Vedotin
n=20 Participants
Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses. Patients in the new cohort receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
|
Cohort #2
Patients receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
|
|---|---|---|
|
Complete Response (CR) Rate in Cohort #2
|
55.0 percentage of participants with response
Interval 31.5 to 76.9
|
—
|
SECONDARY outcome
Timeframe: 60 days after completion of last course of study treatment, up to conditioning regimensPopulation: Among the 57 enrolled patients, 50 patients receive BV followed by AutoHCT, 32 in Cohort #1 and 18 in Cohort #2.
Among the patients receiving salvage Brentuximab Vedotin (BV) followed by Autologous Hematopoietic Stem Cell Transplantation (AutoHCT), their total CD34+ cell yield by stem cell mobilization.
Outcome measures
| Measure |
Patients Receive Brentuximab Vedotin
n=32 Participants
Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses. Patients in the new cohort receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
|
Cohort #2
n=18 Participants
Patients receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
|
|---|---|---|
|
Total CD34+ Cell Dose Among Patients Receiving Brentuximab Vedotin Followed by Autologous Hematopoietic Stem Cell Transplantation
|
6.0 x10^6 cells/kg
Interval 2.6 to 34.0
|
8.0 x10^6 cells/kg
Interval 2.8 to 30.5
|
SECONDARY outcome
Timeframe: Assessed for up to 5 years, at least half of the surviving participants followed 2+ yearsPopulation: Among the 57 patients receiving BV, only 50 patients had undergone autologous transplants.
Progression Free Survival (PFS) defined as the time from first treatment day (post AHCT) until objective or symptomatic relapse or death as a result of lymphoma or acute toxicity of treatment. Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formula.
Outcome measures
| Measure |
Patients Receive Brentuximab Vedotin
n=50 Participants
Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses. Patients in the new cohort receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
|
Cohort #2
Patients receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
|
|---|---|---|
|
Progression Free Survival at Year Two Among AutoHCT Patients With BV
|
0.67 survival probability
Interval 0.52 to 0.78
|
—
|
SECONDARY outcome
Timeframe: Assessed for up to 5 years, at least half of the surviving participants followed 2+ yearsPopulation: Among the 57 patients receiving BV, only 50 patients had undergone autologous transplants.
Overall Survival (OS) defined as the time from first treatment day (post AHCT) until death. Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formula.
Outcome measures
| Measure |
Patients Receive Brentuximab Vedotin
n=50 Participants
Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses. Patients in the new cohort receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
|
Cohort #2
Patients receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
|
|---|---|---|
|
Overall Survival at Year Two Among AutoHCT Patients With BV
|
0.93 survival probability
Interval 0.8 to 0.98
|
—
|
Adverse Events
Cohort #1
Serious events: 4 serious events
Other events: 37 other events
Deaths: 6 deaths
Cohort #2
Serious events: 0 serious events
Other events: 20 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cohort #1
n=37 participants at risk
Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses.
|
Cohort #2
n=20 participants at risk
Patients receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
|
|---|---|---|
|
General disorders
Fever
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
General disorders
Non-cardiac chest pain
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Nervous system disorders
Depressed level of consciousness
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
Other adverse events
| Measure |
Cohort #1
n=37 participants at risk
Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses.
|
Cohort #2
n=20 participants at risk
Patients receive regular study dose of brentuximab vedotin for courses 1 and 2. Patients not achieving CR after 2 courses receive higher-dose brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
|
|---|---|---|
|
General disorders
Edema limbs
|
8.1%
3/37 • Number of events 3 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Nervous system disorders
Dizziness
|
5.4%
2/37 • Number of events 2 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Blood and lymphatic system disorders
Anemia
|
21.6%
8/37 • Number of events 9 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
25.0%
5/20 • Number of events 5 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Cardiac disorders
Palpitations
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Cardiac disorders
Sinus tachycardia
|
13.5%
5/37 • Number of events 5 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
15.0%
3/20 • Number of events 3 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Ear and labyrinth disorders
External ear inflammation
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Ear and labyrinth disorders
Tinnitus
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
10.0%
2/20 • Number of events 2 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/37 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
18.9%
7/37 • Number of events 7 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
10.0%
2/20 • Number of events 2 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Gastrointestinal disorders
Constipation
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
5.4%
2/37 • Number of events 2 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
10.0%
2/20 • Number of events 2 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Gastrointestinal disorders
Nausea
|
21.6%
8/37 • Number of events 11 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
30.0%
6/20 • Number of events 7 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
General disorders
Chills
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
15.0%
3/20 • Number of events 4 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
General disorders
Edema face
|
0.00%
0/37 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
General disorders
Fatigue
|
29.7%
11/37 • Number of events 11 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
25.0%
5/20 • Number of events 5 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
General disorders
Fever
|
10.8%
4/37 • Number of events 4 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
20.0%
4/20 • Number of events 4 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
General disorders
Flu like symptoms
|
8.1%
3/37 • Number of events 3 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
General disorders
Gait disturbance
|
8.1%
3/37 • Number of events 3 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
General disorders
Infusion related reaction
|
0.00%
0/37 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 2 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
General disorders
Non-cardiac chest pain
|
8.1%
3/37 • Number of events 5 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
General disorders
Pain
|
0.00%
0/37 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/37 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Infections and infestations
Nail infection
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/37 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Infections and infestations
Skin infection
|
0.00%
0/37 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Infections and infestations
Upper respiratory infection
|
16.2%
6/37 • Number of events 6 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
10.0%
2/20 • Number of events 2 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Infections and infestations
Urinary tract infection
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/37 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Investigations
Alanine aminotransferase increased
|
37.8%
14/37 • Number of events 15 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
45.0%
9/20 • Number of events 9 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Investigations
Alkaline phosphatase increased
|
10.8%
4/37 • Number of events 5 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Investigations
Aspartate aminotransferase increased
|
45.9%
17/37 • Number of events 21 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
40.0%
8/20 • Number of events 9 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Investigations
Blood bilirubin increased
|
8.1%
3/37 • Number of events 4 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Investigations
Cholesterol high
|
13.5%
5/37 • Number of events 5 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Investigations
Creatinine increased
|
5.4%
2/37 • Number of events 2 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Investigations
INR increased
|
0.00%
0/37 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Investigations
Investigations - Other, specify
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Investigations
Lymphocyte count decreased
|
10.8%
4/37 • Number of events 4 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/37 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
10.0%
2/20 • Number of events 2 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Investigations
Neutrophil count decreased
|
13.5%
5/37 • Number of events 8 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Investigations
Platelet count decreased
|
8.1%
3/37 • Number of events 4 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Investigations
Weight gain
|
0.00%
0/37 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
10.0%
2/20 • Number of events 2 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Investigations
Weight loss
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Investigations
White blood cell decreased
|
21.6%
8/37 • Number of events 10 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 2 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
10.8%
4/37 • Number of events 4 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
10.0%
2/20 • Number of events 2 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.7%
1/37 • Number of events 2 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.8%
4/37 • Number of events 5 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.4%
2/37 • Number of events 2 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
13.5%
5/37 • Number of events 6 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
25.0%
5/20 • Number of events 6 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.4%
2/37 • Number of events 2 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.8%
4/37 • Number of events 4 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
32.4%
12/37 • Number of events 15 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
35.0%
7/20 • Number of events 8 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
10.0%
2/20 • Number of events 3 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
13.5%
5/37 • Number of events 5 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
25.0%
5/20 • Number of events 7 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.4%
2/37 • Number of events 2 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
25.0%
5/20 • Number of events 5 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.4%
2/37 • Number of events 3 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/37 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
21.6%
8/37 • Number of events 8 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
15.0%
3/20 • Number of events 3 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.7%
1/37 • Number of events 2 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.4%
2/37 • Number of events 2 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/37 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.2%
6/37 • Number of events 7 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
15.0%
3/20 • Number of events 4 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/37 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
10.0%
2/20 • Number of events 2 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Nervous system disorders
Depressed level of consciousness
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Nervous system disorders
Headache
|
8.1%
3/37 • Number of events 4 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
15.0%
3/20 • Number of events 3 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
43.2%
16/37 • Number of events 17 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
35.0%
7/20 • Number of events 11 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Nervous system disorders
Presyncope
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Nervous system disorders
Somnolence
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Psychiatric disorders
Anxiety
|
5.4%
2/37 • Number of events 2 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Psychiatric disorders
Confusion
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Psychiatric disorders
Depression
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Psychiatric disorders
Insomnia
|
8.1%
3/37 • Number of events 3 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Renal and urinary disorders
Proteinuria
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Renal and urinary disorders
Urinary tract pain
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Reproductive system and breast disorders
Irregular menstruation
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Reproductive system and breast disorders
Menorrhagia
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.1%
3/37 • Number of events 3 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
25.0%
5/20 • Number of events 5 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.5%
5/37 • Number of events 6 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
10.0%
2/20 • Number of events 2 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/37 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
10.0%
2/20 • Number of events 3 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.4%
2/37 • Number of events 2 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
15.0%
3/20 • Number of events 3 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.4%
2/37 • Number of events 2 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/37 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.4%
2/37 • Number of events 2 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
10.0%
2/20 • Number of events 2 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.9%
7/37 • Number of events 7 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
35.0%
7/20 • Number of events 7 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
27.0%
10/37 • Number of events 16 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
18.9%
7/37 • Number of events 7 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
45.0%
9/20 • Number of events 12 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
5.4%
2/37 • Number of events 2 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Vascular disorders
Hot flashes
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
0.00%
0/20 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Vascular disorders
Hypertension
|
24.3%
9/37 • Number of events 11 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
55.0%
11/20 • Number of events 15 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
|
Vascular disorders
Hypotension
|
2.7%
1/37 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
5.0%
1/20 • Number of events 1 • Death was monitored from Day 0 up to Year 5. Serious and other adverse events were assessed after each cycle of treatment, up to 5 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place