Trial Outcomes & Findings for Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients (NCT NCT01546571)
NCT ID: NCT01546571
Last Updated: 2025-10-24
Results Overview
This is an event driven trial. Recurrence-free survival time (RFS) is computed from the earliest of the date of recurrence or death or, if without recurrence or death, the date last assessed for recurrence without diagnosis of recurrence (censored). The date of recurrence is specified as the first date a recurrence is suspected, which is later confirmed by biopsy.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
504 participants
Primary outcome timeframe
432 events or 8 years and 10 months
Results posted on
2025-10-24
Participant Flow
Part A (dose finding) was competitive enrollment from 6/1/2012 to 10/16/2013. Part B1 of the protocol was competitive enrollment from 1/1/2015 to 8/16/2016. The study was halted prior to Part B2. Types of sites range from clinical oncologist, dermatological and surgical oncologist.
Participant milestones
| Measure |
Part A POL-103A 40 Micrograms/Dose
POL-103A: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part A POL-103A 100 Micrograms/Dose
POL-103A: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part A Without API
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part B1 POL-103A 40 Micrograms/Dose
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part B1 POL-103A Without API
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
52
|
52
|
53
|
230
|
117
|
|
Overall Study
COMPLETED
|
29
|
29
|
7
|
141
|
74
|
|
Overall Study
NOT COMPLETED
|
23
|
23
|
46
|
89
|
43
|
Reasons for withdrawal
| Measure |
Part A POL-103A 40 Micrograms/Dose
POL-103A: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part A POL-103A 100 Micrograms/Dose
POL-103A: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part A Without API
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part B1 POL-103A 40 Micrograms/Dose
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part B1 POL-103A Without API
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
assigned placebo in Part A
|
0
|
0
|
22
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
2
|
3
|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Disease Progression
|
20
|
18
|
15
|
73
|
37
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
4
|
9
|
2
|
|
Overall Study
Intercurrent Illness
|
1
|
2
|
0
|
0
|
0
|
|
Overall Study
Other Cancers
|
0
|
0
|
0
|
3
|
1
|
|
Overall Study
Other
|
0
|
0
|
3
|
0
|
0
|
Baseline Characteristics
Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients
Baseline characteristics by cohort
| Measure |
Part A POL-103A 40microgram/Dose
n=52 Participants
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part A POL-103A 100 Microgram/Dose
n=52 Participants
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part A POL-103A Without API
n=53 Participants
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part B1 POL-103A
n=230 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part B1 POL-103A Without API
n=117 Participants
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Total
n=504 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 9.74 • n=5 Participants
|
53.8 years
STANDARD_DEVIATION 12.73 • n=7 Participants
|
55.8 years
STANDARD_DEVIATION 14.90 • n=5 Participants
|
56.3 years
STANDARD_DEVIATION 12.73 • n=4 Participants
|
55.8 years
STANDARD_DEVIATION 13.73 • n=21 Participants
|
56.1 years
STANDARD_DEVIATION 13.06 • n=10 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
202 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
302 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
222 Participants
n=4 Participants
|
113 Participants
n=21 Participants
|
487 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Region of Enrollment
North America
|
52 participants
n=5 Participants
|
52 participants
n=7 Participants
|
53 participants
n=5 Participants
|
230 participants
n=4 Participants
|
117 participants
n=21 Participants
|
504 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 432 events or 8 years and 10 monthsPopulation: Overall Status of patients at the end of the study. This is applicable to Part B1 only. Study was halted prior to Part B2.
This is an event driven trial. Recurrence-free survival time (RFS) is computed from the earliest of the date of recurrence or death or, if without recurrence or death, the date last assessed for recurrence without diagnosis of recurrence (censored). The date of recurrence is specified as the first date a recurrence is suspected, which is later confirmed by biopsy.
Outcome measures
| Measure |
POL-103A
n=37 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part B1 POL-103A-Stage IIB/IIC
n=74 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A-IIIA
n=69 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-IIIA
n=34 Participants
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A -IIIB/IIIC
n=87 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-IIIB/IIIC
n=46 Participants
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A All Randomized
n=230 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-All Randomized
n=117 Participants
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
|---|---|---|---|---|---|---|---|---|
|
Part B1: Recurrence Free Survival (RFS)
Participants censored
|
17 Participants
|
42 Participants
|
51 Participants
|
21 Participants
|
36 Participants
|
23 Participants
|
129 Participants
|
61 Participants
|
|
Part B1: Recurrence Free Survival (RFS)
Participants with recurrence
|
20 Participants
|
32 Participants
|
18 Participants
|
13 Participants
|
51 Participants
|
23 Participants
|
101 Participants
|
56 Participants
|
PRIMARY outcome
Timeframe: Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for WM range 1.Population: The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin.
For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.
Outcome measures
| Measure |
POL-103A
n=17 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part B1 POL-103A-Stage IIB/IIC
n=20 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A-IIIA
n=27 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-IIIA
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A -IIIB/IIIC
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-IIIB/IIIC
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A All Randomized
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-All Randomized
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
|---|---|---|---|---|---|---|---|---|
|
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight MW) Range 1 [0,20)
|
7.3 percentage of change in bands
Standard Deviation 26.1
|
6.8 percentage of change in bands
Standard Deviation 44.9
|
-1.8 percentage of change in bands
Standard Deviation 29.8
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 2Population: The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin.
For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.
Outcome measures
| Measure |
POL-103A
n=29 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part B1 POL-103A-Stage IIB/IIC
n=20 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A-IIIA
n=28 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-IIIA
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A -IIIB/IIIC
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-IIIB/IIIC
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A All Randomized
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-All Randomized
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
|---|---|---|---|---|---|---|---|---|
|
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 2 [20,28)
|
12.0 percentage of change in bands
Standard Deviation 38.4
|
0.4 percentage of change in bands
Standard Deviation 22.3
|
-6.2 percentage of change in bands
Standard Deviation 16.3
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 3Population: The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin.
For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.
Outcome measures
| Measure |
POL-103A
n=21 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part B1 POL-103A-Stage IIB/IIC
n=19 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A-IIIA
n=24 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-IIIA
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A -IIIB/IIIC
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-IIIB/IIIC
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A All Randomized
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-All Randomized
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
|---|---|---|---|---|---|---|---|---|
|
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 3 [28,36)
|
9.3 percentage of change in bands
Standard Deviation 32.9
|
14.8 percentage of change in bands
Standard Deviation 74.2
|
0.5 percentage of change in bands
Standard Deviation 35.1
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 4Population: The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin.
For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.
Outcome measures
| Measure |
POL-103A
n=21 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part B1 POL-103A-Stage IIB/IIC
n=27 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A-IIIA
n=28 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-IIIA
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A -IIIB/IIIC
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-IIIB/IIIC
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A All Randomized
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-All Randomized
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
|---|---|---|---|---|---|---|---|---|
|
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 4 [36,44)
|
7.6 percentage of change in bands
Standard Deviation 20.7
|
5.3 percentage of change in bands
Standard Deviation 24.6
|
8.5 percentage of change in bands
Standard Deviation 43.5
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 5Population: The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin.
For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.
Outcome measures
| Measure |
POL-103A
n=27 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part B1 POL-103A-Stage IIB/IIC
n=27 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A-IIIA
n=36 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-IIIA
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A -IIIB/IIIC
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-IIIB/IIIC
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A All Randomized
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-All Randomized
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
|---|---|---|---|---|---|---|---|---|
|
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 5 [44,53)
|
9.5 percentage of change in bands
Standard Deviation 43.3
|
1.3 percentage of change in bands
Standard Deviation 23.1
|
10.3 percentage of change in bands
Standard Deviation 33.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 6Population: The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin.
For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.
Outcome measures
| Measure |
POL-103A
n=10 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part B1 POL-103A-Stage IIB/IIC
n=74 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A-IIIA
n=10 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-IIIA
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A -IIIB/IIIC
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-IIIB/IIIC
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A All Randomized
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-All Randomized
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
|---|---|---|---|---|---|---|---|---|
|
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 6 [53,62)
|
18.8 percentage of change in bands
Standard Deviation 49.0
|
-12.7 percentage of change in bands
Standard Deviation 19.5
|
14.4 percentage of change in bands
Standard Deviation 29.1
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 7Population: The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin.
For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.
Outcome measures
| Measure |
POL-103A
n=20 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part B1 POL-103A-Stage IIB/IIC
n=21 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A-IIIA
n=21 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-IIIA
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A -IIIB/IIIC
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-IIIB/IIIC
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A All Randomized
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-All Randomized
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
|---|---|---|---|---|---|---|---|---|
|
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 7 [62,72)
|
5.5 percentage of change in bands
Standard Deviation 22.7
|
6.8 percentage of change in bands
Standard Deviation 24.4
|
7.9 percentage of change in bands
Standard Deviation 28.4
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 8Population: The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin.
For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.
Outcome measures
| Measure |
POL-103A
n=33 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part B1 POL-103A-Stage IIB/IIC
n=31 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A-IIIA
n=32 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-IIIA
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A -IIIB/IIIC
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-IIIB/IIIC
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A All Randomized
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-All Randomized
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
|---|---|---|---|---|---|---|---|---|
|
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 8 [72,83)
|
0.4 percentage of change in bands
Standard Deviation 16.8
|
-0.0 percentage of change in bands
Standard Deviation 18.2
|
10.5 percentage of change in bands
Standard Deviation 35.9
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 9Population: The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin.
For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.
Outcome measures
| Measure |
POL-103A
n=17 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part B1 POL-103A-Stage IIB/IIC
n=16 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A-IIIA
n=18 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-IIIA
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A -IIIB/IIIC
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-IIIB/IIIC
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A All Randomized
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-All Randomized
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
|---|---|---|---|---|---|---|---|---|
|
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 9 [83,94)
|
16.8 percentage of change in bands
Standard Deviation 25.6
|
-0.8 percentage of change in bands
Standard Deviation 24.3
|
5.9 percentage of change in bands
Standard Deviation 34.7
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 10Population: The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin.
For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.
Outcome measures
| Measure |
POL-103A
n=22 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part B1 POL-103A-Stage IIB/IIC
n=24 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A-IIIA
n=30 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-IIIA
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A -IIIB/IIIC
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-IIIB/IIIC
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A All Randomized
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-All Randomized
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
|---|---|---|---|---|---|---|---|---|
|
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 10 [94,105)
|
4.0 percentage of change in bands
Standard Deviation 21.4
|
13.7 percentage of change in bands
Standard Deviation 31.4
|
9.9 percentage of change in bands
Standard Deviation 27.5
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 11Population: The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin.
For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.
Outcome measures
| Measure |
POL-103A
n=23 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part B1 POL-103A-Stage IIB/IIC
n=28 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A-IIIA
n=25 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-IIIA
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A -IIIB/IIIC
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-IIIB/IIIC
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A All Randomized
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-All Randomized
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
|---|---|---|---|---|---|---|---|---|
|
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 11 [105,118)
|
1.0 percentage of change in bands
Standard Deviation 19.3
|
5.1 percentage of change in bands
Standard Deviation 23.8
|
5.0 percentage of change in bands
Standard Deviation 31.7
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 12Population: The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin.
For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.
Outcome measures
| Measure |
POL-103A
n=7 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part B1 POL-103A-Stage IIB/IIC
n=12 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A-IIIA
n=9 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-IIIA
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A -IIIB/IIIC
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-IIIB/IIIC
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A All Randomized
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-All Randomized
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
|---|---|---|---|---|---|---|---|---|
|
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 12 [118,Inf)
|
-5.3 percentage of change in bands
Standard Deviation 20.1
|
2.3 percentage of change in bands
Standard Deviation 15.9
|
-15.5 percentage of change in bands
Standard Deviation 26.9
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Overall survival (OS) was measured from randomization until death from any cause, assessed up to 76 months.Population: Part B1 participants randomized to seviprotimut-L 40 μg or placebo. Part B2 was not initiated.
Overall survival (OS) analyses were based on the ITT analysis set; OS was defined as the duration from randomization until death. If the patient was alive, OS was censored at the earliest date the participant was known to be alive or the date of data cutoff.
Outcome measures
| Measure |
POL-103A
n=230 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part B1 POL-103A-Stage IIB/IIC
n=117 Participants
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A-IIIA
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-IIIA
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A -IIIB/IIIC
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-IIIB/IIIC
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A All Randomized
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
Part B1 POL-103A Without API-All Randomized
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
|
|---|---|---|---|---|---|---|---|---|
|
Part B1: Overall Survival (OS)
|
201 Participants
|
97 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A POL-103A 40 Micrograms/Dose
Serious events: 0 serious events
Other events: 48 other events
Deaths: 12 deaths
Part A POL-103A 100 Micrograms/Dose
Serious events: 0 serious events
Other events: 51 other events
Deaths: 12 deaths
Part A POL-103A Without API
Serious events: 0 serious events
Other events: 51 other events
Deaths: 6 deaths
Part B1 POL-103A
Serious events: 0 serious events
Other events: 212 other events
Deaths: 29 deaths
Part B1 POL-103A Without API
Serious events: 0 serious events
Other events: 113 other events
Deaths: 20 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A POL-103A 40 Micrograms/Dose
n=52 participants at risk
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part A POL-103A 100 Micrograms/Dose
n=52 participants at risk
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part A POL-103A Without API
n=53 participants at risk
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part B1 POL-103A
n=230 participants at risk
POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
Part B1 POL-103A Without API
n=117 participants at risk
POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years.
|
|---|---|---|---|---|---|
|
Infections and infestations
Injection site erythema
|
25.0%
13/52 • Number of events 87 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
30.8%
16/52 • Number of events 267 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
34.0%
18/53 • Number of events 261 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
31.7%
73/230 • Number of events 583 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
42.7%
50/117 • Number of events 307 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
General disorders
Fatigue
|
32.7%
17/52 • Number of events 24 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
25.0%
13/52 • Number of events 19 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
30.2%
16/53 • Number of events 19 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
27.8%
64/230 • Number of events 97 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
35.9%
42/117 • Number of events 64 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Infections and infestations
Injection site pruritus
|
7.7%
4/52 • Number of events 10 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
15.4%
8/52 • Number of events 54 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
7.5%
4/53 • Number of events 17 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
20.0%
46/230 • Number of events 374 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
13.7%
16/117 • Number of events 64 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Nervous system disorders
Headache
|
13.5%
7/52 • Number of events 8 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
13.5%
7/52 • Number of events 8 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
7.5%
4/53 • Number of events 6 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
14.8%
34/230 • Number of events 56 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
19.7%
23/117 • Number of events 33 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Infections and infestations
Injection site pain
|
1.9%
1/52 • Number of events 2 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
7.7%
4/52 • Number of events 24 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.7%
3/53 • Number of events 10 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
13.9%
32/230 • Number of events 319 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
11.1%
13/117 • Number of events 153 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
General disorders
Nausea
|
15.4%
8/52 • Number of events 13 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
9.6%
5/52 • Number of events 8 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
9.4%
5/53 • Number of events 5 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
13.5%
31/230 • Number of events 40 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
9.4%
11/117 • Number of events 13 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
13/52 • Number of events 17 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
9.6%
5/52 • Number of events 5 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.7%
3/53 • Number of events 3 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
9.1%
21/230 • Number of events 26 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
15.4%
18/117 • Number of events 21 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Gastrointestinal disorders
Diarrhea
|
13.5%
7/52 • Number of events 10 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
11.5%
6/52 • Number of events 7 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.8%
2/53 • Number of events 2 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
8.7%
20/230 • Number of events 26 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
11.1%
13/117 • Number of events 19 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
4/52 • Number of events 6 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.8%
2/52 • Number of events 2 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.7%
3/53 • Number of events 3 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.7%
13/230 • Number of events 14 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
11.1%
13/117 • Number of events 14 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
7.7%
4/52 • Number of events 7 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
11.5%
6/52 • Number of events 7 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.8%
2/53 • Number of events 3 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
7.0%
16/230 • Number of events 21 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
10.3%
12/117 • Number of events 12 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.5%
6/52 • Number of events 7 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
7.7%
4/52 • Number of events 6 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
1.9%
1/53 • Number of events 1 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
8.3%
19/230 • Number of events 22 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
12.8%
15/117 • Number of events 20 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Eye disorders
Cataract
|
7.7%
4/52 • Number of events 5 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.8%
3/52 • Number of events 5 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
1.9%
1/53 • Number of events 1 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.0%
7/230 • Number of events 7 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
7.7%
9/117 • Number of events 9 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Gastrointestinal disorders
Vomiting
|
5.8%
3/52 • Number of events 4 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.8%
2/52 • Number of events 2 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
1.9%
1/53 • Number of events 1 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.5%
8/230 • Number of events 10 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
6.0%
7/117 • Number of events 8 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
General disorders
Injection site urticaria
|
11.5%
6/52 • Number of events 108 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
15.4%
8/52 • Number of events 116 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
9.4%
5/53 • Number of events 51 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
2.2%
5/230 • Number of events 52 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
0.00%
0/117 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
General disorders
Injection site nodule
|
1.9%
1/52 • Number of events 1 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
9.6%
5/52 • Number of events 20 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
11.3%
6/53 • Number of events 39 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
2.2%
5/230 • Number of events 8 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
1.7%
2/117 • Number of events 5 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
General disorders
Influenza like illness
|
7.7%
4/52 • Number of events 8 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.8%
2/52 • Number of events 2 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
15.1%
8/53 • Number of events 12 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.7%
13/230 • Number of events 26 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
6.8%
8/117 • Number of events 9 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
General disorders
Oedema Peripheral
|
7.7%
4/52 • Number of events 5 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.8%
3/52 • Number of events 3 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
1.9%
1/53 • Number of events 1 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
7.4%
17/230 • Number of events 21 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
4.3%
5/117 • Number of events 5 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
General disorders
Injection site swelling
|
3.8%
2/52 • Number of events 4 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.8%
3/52 • Number of events 24 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.7%
3/53 • Number of events 13 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
6.5%
15/230 • Number of events 97 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.1%
6/117 • Number of events 19 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
General disorders
Injection site bruising
|
0.00%
0/52 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
0.00%
0/52 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
0.00%
0/53 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.7%
13/230 • Number of events 18 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.1%
6/117 • Number of events 8 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
General disorders
Injection site induration
|
5.8%
3/52 • Number of events 43 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.8%
3/52 • Number of events 38 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.8%
2/53 • Number of events 32 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.9%
9/230 • Number of events 28 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
2.6%
3/117 • Number of events 66 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
General disorders
Peripheral swelling
|
9.6%
5/52 • Number of events 7 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
1.9%
1/52 • Number of events 1 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
1.9%
1/53 • Number of events 1 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
1.3%
3/230 • Number of events 3 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.4%
4/117 • Number of events 5 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
General disorders
Injection site rash
|
5.8%
3/52 • Number of events 4 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
1.9%
1/52 • Number of events 18 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.8%
2/53 • Number of events 6 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.5%
8/230 • Number of events 15 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.4%
4/117 • Number of events 7 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
General disorders
Pain
|
5.8%
3/52 • Number of events 3 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
0.00%
0/52 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
1.9%
1/53 • Number of events 1 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
2.2%
5/230 • Number of events 8 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
1.7%
2/117 • Number of events 2 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
4/52 • Number of events 4 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
11.5%
6/52 • Number of events 6 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
1.9%
1/53 • Number of events 1 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
11.3%
26/230 • Number of events 27 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
7.7%
9/117 • Number of events 13 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Infections and infestations
Sinusitis
|
5.8%
3/52 • Number of events 3 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.8%
2/52 • Number of events 2 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.7%
3/53 • Number of events 4 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.7%
13/230 • Number of events 15 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.4%
4/117 • Number of events 4 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
2/52 • Number of events 2 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.8%
2/52 • Number of events 2 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.7%
3/53 • Number of events 4 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
6.5%
15/230 • Number of events 15 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
12.0%
14/117 • Number of events 18 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Infections and infestations
Urinary tract infection
|
1.9%
1/52 • Number of events 1 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.8%
2/52 • Number of events 2 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
7.5%
4/53 • Number of events 4 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.7%
13/230 • Number of events 15 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
8.5%
10/117 • Number of events 12 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/52 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
1.9%
1/52 • Number of events 1 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
7.5%
4/53 • Number of events 4 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
2.2%
5/230 • Number of events 5 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.4%
4/117 • Number of events 4 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Infections and infestations
Cellulitis
|
1.9%
1/52 • Number of events 1 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.8%
3/52 • Number of events 3 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
0.00%
0/53 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.0%
7/230 • Number of events 10 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
2.6%
3/117 • Number of events 4 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.8%
2/52 • Number of events 2 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
0.00%
0/52 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.8%
2/53 • Number of events 3 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
1.3%
3/230 • Number of events 5 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.1%
6/117 • Number of events 6 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/52 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
7.7%
4/52 • Number of events 4 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
0.00%
0/53 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.0%
7/230 • Number of events 7 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.4%
4/117 • Number of events 5 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.8%
3/52 • Number of events 3 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
7.7%
4/52 • Number of events 4 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
7.5%
4/53 • Number of events 5 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
7.0%
16/230 • Number of events 22 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
9.4%
11/117 • Number of events 16 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.8%
3/52 • Number of events 3 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
11.5%
6/52 • Number of events 6 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
1.9%
1/53 • Number of events 1 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.7%
13/230 • Number of events 16 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
6.8%
8/117 • Number of events 8 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
11.5%
6/52 • Number of events 7 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
9.6%
5/52 • Number of events 6 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.8%
2/53 • Number of events 2 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
7.0%
16/230 • Number of events 21 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.1%
6/117 • Number of events 9 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
5.8%
3/52 • Number of events 5 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.8%
2/52 • Number of events 2 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
9.4%
5/53 • Number of events 7 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
6.5%
15/230 • Number of events 22 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.4%
4/117 • Number of events 4 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
5.8%
3/52 • Number of events 3 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
1.9%
1/52 • Number of events 2 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
0.00%
0/53 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
0.00%
0/230 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
0.00%
0/117 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dysplastic Naevus
|
5.8%
3/52 • Number of events 7 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.8%
3/52 • Number of events 4 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
1.9%
1/53 • Number of events 1 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.9%
9/230 • Number of events 10 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
2.6%
3/117 • Number of events 4 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
7.7%
4/52 • Number of events 4 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
0.00%
0/52 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.8%
2/53 • Number of events 4 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.9%
9/230 • Number of events 11 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
2.6%
3/117 • Number of events 6 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Nervous system disorders
Dizziness
|
9.6%
5/52 • Number of events 5 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
13.5%
7/52 • Number of events 7 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
1.9%
1/53 • Number of events 1 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.7%
13/230 • Number of events 14 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
6.0%
7/117 • Number of events 8 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Nervous system disorders
Paraesthesia
|
1.9%
1/52 • Number of events 1 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.8%
2/52 • Number of events 2 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
0.00%
0/53 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.9%
9/230 • Number of events 9 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
6.0%
7/117 • Number of events 10 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Nervous system disorders
Syncope
|
0.00%
0/52 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
0.00%
0/52 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
0.00%
0/53 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
1.3%
3/230 • Number of events 3 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.1%
6/117 • Number of events 7 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Psychiatric disorders
Insomia
|
7.7%
4/52 • Number of events 7 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
9.6%
5/52 • Number of events 7 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.7%
3/53 • Number of events 3 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.2%
12/230 • Number of events 16 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
2.6%
3/117 • Number of events 3 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/52 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
0.00%
0/52 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.7%
3/53 • Number of events 3 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
4.3%
10/230 • Number of events 11 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
6.0%
7/117 • Number of events 8 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Renal and urinary disorders
Haematuria
|
9.6%
5/52 • Number of events 6 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.8%
3/52 • Number of events 3 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
7.5%
4/53 • Number of events 4 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
0.87%
2/230 • Number of events 2 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
0.00%
0/117 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.5%
6/52 • Number of events 6 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.8%
3/52 • Number of events 3 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
0.00%
0/53 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.5%
8/230 • Number of events 8 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.4%
4/117 • Number of events 4 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.8%
3/52 • Number of events 4 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
1.9%
1/52 • Number of events 1 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
0.00%
0/53 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.9%
9/230 • Number of events 10 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
1.7%
2/117 • Number of events 2 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.6%
5/52 • Number of events 8 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
9.6%
5/52 • Number of events 6 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
7.5%
4/53 • Number of events 4 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
9.6%
22/230 • Number of events 27 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
6.8%
8/117 • Number of events 9 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Skin and subcutaneous tissue disorders
Actinic Keratosis
|
5.8%
3/52 • Number of events 4 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
50.0%
26/52 • Number of events 26 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
7.5%
4/53 • Number of events 7 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
6.5%
15/230 • Number of events 37 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
6.0%
7/117 • Number of events 7 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/52 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
0.00%
0/52 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
0.00%
0/53 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
2.2%
5/230 • Number of events 7 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.1%
6/117 • Number of events 9 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.9%
1/52 • Number of events 1 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
11.5%
6/52 • Number of events 7 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.8%
2/53 • Number of events 2 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.5%
8/230 • Number of events 9 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
2.6%
3/117 • Number of events 3 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.9%
1/52 • Number of events 1 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
7.7%
4/52 • Number of events 4 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
1.9%
1/53 • Number of events 1 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.5%
8/230 • Number of events 9 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
2.6%
3/117 • Number of events 3 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Vascular disorders
Lymphoedema
|
5.8%
3/52 • Number of events 3 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.8%
2/52 • Number of events 3 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
7.5%
4/53 • Number of events 4 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.9%
9/230 • Number of events 10 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.1%
6/117 • Number of events 8 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Vascular disorders
Hypertension
|
3.8%
2/52 • Number of events 2 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.8%
2/52 • Number of events 2 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
1.9%
1/53 • Number of events 1 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
6.5%
15/230 • Number of events 17 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.4%
4/117 • Number of events 6 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
9.6%
5/52 • Number of events 7 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
1.9%
1/52 • Number of events 1 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
5.7%
3/53 • Number of events 3 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
2.6%
6/230 • Number of events 6 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
3.4%
4/117 • Number of events 5 • Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place